Cleared Special

K073376 - PHILIPS ECG ALGORITHM

K073376 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
130d
Days
-
Risk

K073376 is an FDA 510(k) clearance for the PHILIPS ECG ALGORITHM.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on April 11, 2008 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Medical Systems devices

Submission Details

510(k) Number K073376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date April 11, 2008
Days to Decision 130 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 41
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K073376.
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PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
K981265 · Hewlett-Packard Co. · Jun 1998
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K974087 · Hewlett-Packard Co. · Jun 1998
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440 · Fukuda Denshi USA, Inc. · Dec 1997