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FDA 510(k)

TRACOE Cuff Pressure Monitor

K-Number: K152778 · 2016-12-21

ApplicantTracoe Medical GmbH
Decision Date2016-12-21
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACOE Cuff Pressure Monitor is a medical device manufactured by Tracoe Medical GmbH. It received FDA 510(k) clearance on 2016-12-21 under approval number K152778. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACOE Cuff Pressure Monitor?

TRACOE Cuff Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Tracoe Medical GmbH. The 510(k) number is K152778.

When was TRACOE Cuff Pressure Monitor approved by the FDA?

TRACOE Cuff Pressure Monitor received FDA 510(k) clearance on 2016-12-21, under approval number K152778.

What company makes TRACOE Cuff Pressure Monitor?

TRACOE Cuff Pressure Monitor is manufactured by Tracoe Medical GmbH.

What is the FDA product code for TRACOE Cuff Pressure Monitor?

The FDA product code for TRACOE Cuff Pressure Monitor is BSK.

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Other Devices by Tracoe Medical GmbH

K152865TRACOE smart Cuff Manager K172720TRACOE silcosoft Tracheostomy Tube K203362TRACOE vario

Related Devices (Code: BSK)

K152865TRACOE smart Cuff ManagerTracoe Medical GmbH K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration , Ltd. K150893IntelliCuffHamilton Medical AG K180991AG 100sHospitech Respiration , Ltd. K173914VORTRAN Cuff Inflator (VCI)Vortran Medical Technology 1, Inc. K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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