K163649 is an FDA 510(k) clearance for the SureSigns VS3. This device is classified as a Alarm, Blood-pressure (Class II - Special Controls, product code DSJ).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on March 31, 2017, 98 days after receiving the submission on December 23, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1100.
| 510(k) Number | K163649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2016 |
| Decision Date | March 31, 2017 |
| Days to Decision | 98 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSJ — Alarm, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1100 |