ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)— 510(k) K213497

Substantially Equivalent

H&abyz Co., Ltd.

FDA 510(k) clearance K213497 for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW), Substantially Equivalent on 2021-11-15. Applicant: H&abyz Co., Ltd..

Clearance details

Applicant
H&abyz Co., Ltd.
Product code
Code MQB
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Yongin-Si, KR
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