Submission Details
| 510(k) Number | K073376 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
PHILIPS ECG ALGORITHM
Apr 2008
Decision
130d
Days
—
Risk
About This 510(k) Submission
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 review panel.
Device Classification
| Product Code | LOS |
| Device Class | — |
Manufacturer
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