ARDO Alyssa
FDA 510(k) clearance K212773 · decided 2022-04-15
Clearance details
- K-number
- K212773
- Device name
- ARDO Alyssa
- Applicant
- Ardo Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2021-08-31
- Decision date
- 2022-04-15
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Unteraegeri, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.