Infant Phototherapy Equipment— 510(k) K210289

Substantially Equivalent

Bistos Co., Ltd.

FDA 510(k) clearance K210289 for Infant Phototherapy Equipment, Substantially Equivalent on 2021-05-28. Applicant: Bistos Co., Ltd..

Clearance details

Applicant: Bistos Co., Ltd.
Product code: Code LBI
Advisory panel: General Hospital
Date received: 2021-02-02
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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