Cleared Traditional

K830907 - AMBULATORY ECG EVENT RECORDER

K830907 is an FDA 510(k) clearance for AMBULATORY ECG EVENT RECORDER, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K830907 · Brentwood Instruments, Inc. · Cardiovascular device
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Jul 1983
Decision
129d
Days
Class 2
Risk

K830907 is an FDA 510(k) clearance for the AMBULATORY ECG EVENT RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Brentwood Instruments, Inc. devices

FDA 510(k) Submission Details - K830907

510(k) Number K830907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date July 28, 1983
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 93
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K830907.
RESPIRATION/8100-HEART RATE RECORDER
K833348 · Aequitron Medical, Inc. · Apr 1984
EVENT TAPE RECORDER 8293
K833349 · Aequitron Medical, Inc. · Apr 1984
ELECTROCARDIOCORDER RECORDER 453
K833661 · Del Mar Avionics · Nov 1983
OMAR
K830915 · Oxford Medilog, Inc. · Jul 1983
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · Marquette Electronics, Inc. · Dec 1982
HOLTER KIT MODEL #5000 SERIES
K823414 · Andover Medical, Inc. · Dec 1982