The following data is part of a premarket notification filed by Lifewatch Technologies Ltd. with the FDA for Cg-6108 Act-3l Continuous Ecg Monitor And Arrhythmia Detector.
| Device ID | K143359 |
| 510k Number | K143359 |
| Device Name: | CG-6108 ACT-3L Continuous ECG Monitor And Arrhythmia Detector |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | LifeWatch Technologies Ltd. 2 Pekeris St. Rehovot, IL 7670202 |
| Contact | Asher Kassel |
| Correspondent | Stephen Slavens Life Watch 10255 W Higgins Road, Suite 100 Chicago, IL 60018 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850725007101 | K143359 | 000 |
| 00850725007033 | K143359 | 000 |
| 00850725007026 | K143359 | 000 |