The following data is part of a premarket notification filed by Fitbit Inc with the FDA for Fitbit Irregular Rhythm Notifications.
| Device ID | K212372 |
| 510k Number | K212372 |
| Device Name: | Fitbit Irregular Rhythm Notifications |
| Classification | Photoplethysmograph Analysis Software For Over-the-counter Use |
| Applicant | Fitbit Inc 199 Fremont Street 14th Floor San Francisco, CA 94105 |
| Contact | Randy Parry |
| Correspondent | Randy Parry Fitbit Inc 199 Fremont Street 14th Floor San Francisco, CA 94105 |
| Product Code | QDB |
| CFR Regulation Number | 870.2790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-30 |
| Decision Date | 2022-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810038852720 | K212372 | 000 |