The following data is part of a premarket notification filed by Lifewatch Technologies Ltd. with the FDA for Vital Signs Patch System.
| Device ID | K151835 |
| 510k Number | K151835 |
| Device Name: | Vital Signs Patch System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | LIFEWATCH TECHNOLOGIES LTD. 2 PEKERIS ST. Rehovot, IL 7670202 |
| Contact | Asher Kassel |
| Correspondent | Asher Kassel LIFEWATCH TECHNOLOGIES LTD. 2 PEKERIS ST. Rehovot, IL 7670202 |
| Product Code | DSI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2016-02-05 |
| Summary: | summary |