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.
Clearance details
- Applicant
- Coala Life AB
- Product code
- Code DXH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.