The following data is part of a premarket notification filed by Lifewatch Technologies Ltd with the FDA for Vital Signs Patch System (in Short Vsp).
| Device ID | K132407 |
| 510k Number | K132407 |
| Device Name: | VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | LIFEWATCH TECHNOLOGIES LTD 2 PEKERIS STREET Rehovot, IL 7670202 |
| Contact | Asher Kassel |
| Correspondent | Asher Kassel LIFEWATCH TECHNOLOGIES LTD 2 PEKERIS STREET Rehovot, IL 7670202 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-02 |
| Decision Date | 2014-12-19 |
| Summary: | summary |