510(k) K182040
K182040 is an FDA 510(k) premarket notification submitted by Coala Life AB for the device "Coala Heart Monitor". The FDA issued a decision of Substantially Equivalent on Feb 8, 2019. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Coala Life AB has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 2019
- Date Received
- Jul 30, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type
- 510(k)