Coala Heart Monitor— 510(k) K182040
Substantially EquivalentCoala Life AB
FDA 510(k) clearance K182040 for Coala Heart Monitor, Substantially Equivalent on 2019-02-08. Applicant: Coala Life AB. Device class: 2.
Clearance details
- Applicant
- Coala Life AB
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
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