K090483 is an FDA 510(k) clearance for the SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on March 20, 2009, 23 days after receiving the submission on February 25, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K090483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2009 |
| Decision Date | March 20, 2009 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |