The following data is part of a premarket notification filed by Empatica S.r.l. with the FDA for Empatica Health Monitoring Platform.
| Device ID | K221282 |
| 510k Number | K221282 |
| Device Name: | Empatica Health Monitoring Platform |
| Classification | Oximeter |
| Applicant | Empatica S.r.l. Via Stendhal, 36 Milan, IT 20144 |
| Contact | Alberto Poli |
| Correspondent | Alberto Poli Empatica S.r.l. Via Stendhal, 36 Milan, IT 20144 |
| Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GZO |
| Subsequent Product Code | LEL |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-03 |
| Decision Date | 2022-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853858006263 | K221282 | 000 |
| 00853858006256 | K221282 | 000 |
| 00853858006249 | K221282 | 000 |
| 00853858006232 | K221282 | 000 |