510(k) K073376
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