More-Cell-System
FDA 510(k) clearance K212659 · decided 2021-11-10
Clearance details
- K-number
- K212659
- Device name
- More-Cell-System
- Applicant
- Agency For Medical Innovations GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-08-23
- Decision date
- 2021-11-10
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- PMU
- Device class
- 2
- Regulation number
- 884.4050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Feldkirch, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.