K-number	K234090
Device name	EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
Applicant	Surgvision GmbH
Product code	IZI
Device class	Class II
Decision date	Mar 20, 2024
Decision	Substantially Equivalent
Regulation	892.1600

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View the full FDA submission: accessdata.fda.gov

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EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)

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