Medical Device Manufacturer · KR , Yongin-Si

H&abyz Co., Ltd.

4 submissions · 4 cleared · Since 2021
4
Total
4
Cleared
0
Denied

H&abyz Co., Ltd. — FDA 510(k) Submissions

H&abyz Co., Ltd. has submitted 4 FDA 510(k) premarket notifications since 2021, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Solid State X-ray Imager (flat Panel/digital Imager), System, X-ray, Mobile . Use the specialty filter in the sidebar to narrow results.

4 devices
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All4 Radiology 4