The following data is part of a premarket notification filed by Lifewatch Services, Inc with the FDA for Lifewatch Mobile Cardiac Telemetry 3 Lead Lifewatch Mct 3l.
| Device ID | K170565 |
| 510k Number | K170565 |
| Device Name: | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | LifeWatch Services, Inc 10255 W Higgins Road Suite 100 Rosemont, IL 60018 |
| Contact | Stefanie Martinez-koenig |
| Correspondent | Stefanie Martinez-koenig LifeWatch Services, Inc 10255 W Higgins Road Suite 100 Rosemont, 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 | 2017-02-27 |
| Decision Date | 2017-08-01 |
| Summary: | summary |