Cleared Traditional

K830666 - APNEA/BRADYCARDIA MONITOR HB 95

K830666 is an FDA 510(k) clearance for APNEA/BRADYCARDIA MONITOR HB 95, manufactured by Harvey-Bostwick, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K830666 · Harvey-Bostwick, Inc. · Cardiovascular device
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Jul 1983
Decision
136d
Days
Class 2
Risk

K830666 is an FDA 510(k) clearance for the APNEA/BRADYCARDIA MONITOR HB 95. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Harvey-Bostwick, Inc. (Walker, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Harvey-Bostwick, Inc. devices

FDA 510(k) Submission Details - K830666

510(k) Number K830666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date July 18, 1983
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 461
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K830666.
SIMPLISCRIPTOR EK 31/101 037 16
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AS 191 ECG TELEMETRY MODULE
K831429 · Narco Scientific · Oct 1983
PATIENT SELECTOR FUNCTION BLOCK
K832212 · Honeywell, Inc. · Oct 1983
CONVERTER UNIT FOR ECG TRACE DISPLAY
K830566 · Honeywell, Inc. · May 1983
ELECTROCARDIOGRAPH #334
K823488 · Birtcher Corp. · Dec 1982
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-
K823584 · Brentwood Instruments, Inc. · Dec 1982