HyperLight Portable X-ray Unit— 510(k) K232068

Substantially Equivalent

Changzhou Sifary Medical Technology Co., Ltd.

FDA 510(k) clearance K232068 for HyperLight Portable X-ray Unit, Substantially Equivalent on 2023-09-01. Applicant: Changzhou Sifary Medical Technology Co., Ltd..

Clearance details

Applicant: Changzhou Sifary Medical Technology Co., Ltd.
Product code: Code EHD
Advisory panel: Dental
Date received: 2023-07-12
Decision date: 2023-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

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