BioXmark
FDA 510(k) clearance DEN220017 · decided 2022-12-23
Clearance details
- K-number
- DEN220017
- Device name
- BioXmark
- Applicant
- Nanovi A/S
- Decision
- Unknown
- Date received
- 2022-03-04
- Decision date
- 2022-12-23
- Days to decision
- 294 days
- Clearance type
- Direct
- Product code
- QUV
- Device class
- 2
- Regulation number
- 892.5727
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kgs. Lyngby, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.