FDA.report

510(k) K234090

Device
EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
Applicant
Surgvision GmbH
510(k) number
K234090
Product code
IZI
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-20
Date received
2023-12-22
Regulation
892.1600
Classification name
System, X-Ray, Angiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Daniela Mahan
Address
Kistlerhofstrasse 70, Bldg. 79 Munich DE 81379 81379

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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