The following data is part of a premarket notification filed by Lifewatch Technologies Ltd. with the FDA for Ecg Mini System Continuous Ecg Monitor And Arrhythmia Detector.
| Device ID | K151269 |
| 510k Number | K151269 |
| Device Name: | ECG Mini System Continuous ECG Monitor And Arrhythmia Detector |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | LifeWatch Technologies Ltd. 2 Pekeris St. Rehovot, IL 0202 |
| Contact | Asher Kassel |
| Correspondent | Donna-bea Tillman Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, VA 22314 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850725007040 | K151269 | 000 |