510(k) K143359
K143359 is an FDA 510(k) premarket notification submitted by Lifewatch Technologies , Ltd. for the device "CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector". The FDA issued a decision of Substantially Equivalent on September 11, 2015. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Lifewatch Technologies , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2015
- Date Received
- November 24, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type