510(k) K073376

PHILIPS ECG ALGORITHM by Philips Medical Systems — Product Code LOS

K073376 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "PHILIPS ECG ALGORITHM". The FDA issued a decision of Substantially Equivalent on April 11, 2008. Philips Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2008
Date Received
December 3, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No