EpiFaith CV
FDA 510(k) clearance K212615 · decided 2022-09-21
Clearance details
- K-number
- K212615
- Device name
- EpiFaith CV
- Applicant
- Flat Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-18
- Decision date
- 2022-09-21
- Days to decision
- 399 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.