Cleared Traditional

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON (K792283) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K792283 · Arzbaecher & Co. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Nov 1979

Decision

Days

Class 2

Risk

K792283 is an FDA 510(k) clearance for the ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON. Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by Arzbaecher & Co. (Walker, US). The FDA issued a Cleared decision on November 21, 1979 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2050 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arzbaecher & Co. devices

Submission Details

510(k) Number	K792283 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 1979
Decision Date	November 21, 1979
Days to Decision	8 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

117d faster than avg

Panel avg: 125d · This submission: 8d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DRR Amplifier And Signal Conditioner, Biopotential
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.2050

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRR Amplifier And Signal Conditioner, Biopotential

All 8

Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K792283.

BARD BIOPOTENTIAL AMPLIFIER

K874441 · C.R. Bard, Inc. · Jan 1988

EPC FILTER

K813123 · Codman & Shurtleff, Inc. · Nov 1981

HP MODEL 8880A FILTER

K802686 · Hewlett-Packard Co. · Nov 1980

MODEL 15055A MAINFRAME

K791964 · Hewlett-Packard Co. · Oct 1979

ESIS MODULE

K780043 · Datascope Corp. · Feb 1978

AMPLIFIER MODULE, 78211A ECG

K772132 · Hewlett-Packard Co. · Nov 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K792283

Arzbaecher & Co.

Walker, MI · US

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active