Blue Eye (TS-905)— 510(k) K220434

Substantially Equivalent

The Standard Co., Ltd.

FDA 510(k) clearance K220434 for Blue Eye (TS-905), Substantially Equivalent on 2022-08-12. Applicant: The Standard Co., Ltd..

Clearance details

Applicant: The Standard Co., Ltd.
Product code: Code PLL
Advisory panel: Gastroenterology, Urology
Date received: 2022-02-15
Decision date: 2022-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

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