510(k) K212163
K212163 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 Apr 14, 2022. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Coala Life AB has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 14, 2022
- Date Received
- Jul 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type
- 510(k)