The following data is part of a premarket notification filed by Lifesignals, Inc. with the FDA for Lifesignals Multi-parameter Remote Monitoring Platform.
| Device ID | K202868 |
| 510k Number | K202868 |
| Device Name: | LifeSignals Multi-Parameter Remote Monitoring Platform |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | LifeSignals, Inc. 39355 California Street, Suite 305 Fremont, CA 94538 |
| Contact | Saravanan Balasubramanian |
| Correspondent | Rita King MethodSense, Inc. One Copley Parkway, Suite 410 Morrisville, NC 27560 |
| Product Code | DRG |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-07-21 |