FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Coala Heart Monitor
K Number: K182040
·
Decision Feb 8, 2019
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
2
Review Days
193
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Basic Information
- Device Name
- Coala Heart Monitor
- K Number
- K182040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coala Life AB
- Date Received
- July 30, 2018
- Decision Date
- February 8, 2019
- Product Code
- DXH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by Coala Life AB
| K Number | Device Name | ||
|---|---|---|---|
| K212163 | Coala Heart Monitor | Apr 14, 2022 | Substantially Equivalent |