K201887 is an FDA 510(k) clearance for the VS Newborn Heart Rate Monitor. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Surepulse Medical Limited (Nottingham, GB). The FDA issued a Cleared decision on July 23, 2021, 380 days after receiving the submission on July 8, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K201887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2020 |
| Decision Date | July 23, 2021 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |