Accucuff Cuff Pressure Indicator— 510(k) K182548

Name: FDA 510(k) clearance K182548
Creator: U.S. Food and Drug Administration
Published: 2019-01-25

Substantially Equivalent

Tianjin Medis Medical Device Co., Ltd.

FDA 510(k) clearance K182548 for Accucuff Cuff Pressure Indicator, Substantially Equivalent on 2019-01-25. Applicant: Tianjin Medis Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tianjin Medis Medical Device Co., Ltd.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2018-09-17
Decision date: 2019-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainjin, CN

Download summary PDF View on FDA.gov ↗

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