Cleared Special

K073376 - PHILIPS ECG ALGORITHM (FDA 510(k) Clearance)

K073376 · Philips Medical Systems · Cardiovascular device

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, 130 days after receiving the submission on December 3, 2007.

This device falls under the Cardiovascular FDA review panel.

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

Device Classification

Product Code	LOS
Device Class	—