510(k) K234090
K234090 is an FDA 510(k) premarket notification submitted by Surgvision GmbH for the device "EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)". The FDA issued a decision of Substantially Equivalent on March 20, 2024. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Surgvision GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2024
- Date Received
- December 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type