K082280 is an FDA 510(k) clearance for the SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on October 8, 2008, 58 days after receiving the submission on August 11, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K082280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2008 |
| Decision Date | October 08, 2008 |
| Days to Decision | 58 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |