Cleared Special

K073376 - PHILIPS ECG ALGORITHM

K073376 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K073376

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.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 82
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K073376 · PHILIPS ECG ALGORITHM
Download PDF FDA Summary Philips Medical Syste…