FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
K Number: K234090
·
Decision Mar 20, 2024
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
- K Number
- K234090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgvision GmbH
- Date Received
- December 22, 2023
- Decision Date
- March 20, 2024
- Product Code
- IZI
- Advisory Committee
- Radiology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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