K190399 is an FDA 510(k) clearance for the Beddr 200 System. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Hancock Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 5, 2019, 167 days after receiving the submission on February 19, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K190399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2019 |
| Decision Date | August 05, 2019 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |