AMADEO, M-UK1015 (incl. attachments and accessories)
FDA 510(k) clearance K213221 · decided 2022-05-26
Clearance details
- K-number
- K213221
- Device name
- AMADEO, M-UK1015 (incl. attachments and accessories)
- Applicant
- W&H Dentalwerk Buermoss GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-09-29
- Decision date
- 2022-05-26
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Buermoos, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.