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510(k) K182548

Accucuff Cuff Pressure Indicator by Tianjin Medis Medical Device Co., Ltd. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2019
Date Received
September 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Tianjin Medis Medical Device Co., Ltd.

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  • K160694 — Disposable Endotracheal tube, sterile, AccuCuff (April 7, 2017)

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