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510(k) K234090

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) by Surgvision GmbH — Product Code IZI

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

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