Explorer Air II
FDA 510(k) clearance K214097 · decided 2022-02-25
Clearance details
- K-number
- K214097
- Device name
- Explorer Air II
- Applicant
- Surgvision GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-12-28
- Decision date
- 2022-02-25
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.