Cleared Traditional

K880357 - OMNIGRAPH 6000

K880357 is the FDA 510(k) clearance for OMNIGRAPH 6000 by Telemed Div.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K880357 · Telemed Div. · Cardiovascular device
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Aug 1988
Decision
187d
Days
Class 2
Risk

K880357 is an FDA 510(k) clearance for the OMNIGRAPH 6000. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Telemed Div. (Hoffman Estates, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 187 days - an extended review cycle.

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 Telemed Div. devices

Submission Details

510(k) Number K880357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1988
Decision Date August 02, 1988
Days to Decision 187 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 254
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K880357.
SYSTEM VI MONITOR
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K882254 · Nihon Kohden America, Inc. · Nov 1988
MINIMON 7131B PATIENT MONITOR
K882197 · Kontron Instruments, Inc. · Aug 1988
MINIMON 7132B PATIENT MONITOR
K882198 · Kontron Instruments, Inc. · Jul 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · Mennen Medical, Inc. · May 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · Fukuda Denshi USA, Inc. · Mar 1988