510(k) K181658
K181658 is an FDA 510(k) premarket notification submitted by Memtec Corporation for the device "MobileECG 2 BT". The FDA issued a decision of Substantially Equivalent on March 26, 2019. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2019
- Date Received
- June 25, 2018
- 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