The following data is part of a premarket notification filed by Fitbit, Inc. with the FDA for Fitbit Ecg App.
| Device ID | K200948 |
| 510k Number | K200948 |
| Device Name: | Fitbit ECG App |
| Classification | Electrocardiograph Software For Over-the-counter Use |
| Applicant | Fitbit, Inc. 199 Fremont Street San Francisco, CA 94105 |
| Contact | Shruti Rajagopalan |
| Correspondent | Shruti Rajagopalan Fitbit, Inc. 199 Fremont Street San Francisco, CA 94105 |
| Product Code | QDA |
| CFR Regulation Number | 870.2345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-08 |
| Decision Date | 2020-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810038851983 | K200948 | 000 |