Cleared Traditional

K832817 - TELEMETRY SYS SERIES 7700 ECG

K832817 is an FDA 510(k) clearance for TELEMETRY SYS SERIES 7700 ECG, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K832817 · Marquette Electronics, Inc. · Cardiovascular device
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Jan 1984
Decision
144d
Days
Class 2
Risk

K832817 is an FDA 510(k) clearance for the TELEMETRY SYS SERIES 7700 ECG. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K832817

510(k) Number K832817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date January 10, 1984
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 167
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K832817.
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
K860239 · Nihon Kohden America, Inc. · Jun 1986
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
K851302 · Quinton, Inc. · May 1985
MODEL 78210A TELEMETRY TRANSMITTER
K844376 · Hewlett-Packard Co. · Jan 1985
LIFESCOPE II/FOUR
K823249 · Nihon Kohden America, Inc. · Nov 1982
EXERCISE ECG ELECTRODES, REUSABLE
K821384 · Respironics, Inc. · Jun 1982
TELEMETRY TRANSMITTER & RECEIVER
K813064 · Honeywell, Inc. · Dec 1981