K221282 is an FDA 510(k) clearance for the Empatica Health Monitoring Platform. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on November 20, 2022, 201 days after receiving the submission on May 3, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K221282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2022 |
| Decision Date | November 20, 2022 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |