The following data is part of a premarket notification filed by Lifesignals, Inc. with the FDA for Lifesignals Ecg Remote Monitoring Patch Platform.
| Device ID | K200690 |
| 510k Number | K200690 |
| Device Name: | LifeSignals ECG Remote Monitoring Patch Platform |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | LifeSignals, Inc. 39355 California Street, Suite 305 Fremont, CA 94538 |
| Contact | Saravanan Balasubramanian |
| Correspondent | Saravanan Balasubramanian LifeSignals, Inc. 39355 California Street, Suite 305 Fremont, CA 94538 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B353LP12502 | K200690 | 000 |
| B353MM12501 | K200690 | 000 |
| B353LP12532 | K200690 | 000 |