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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 the device name listed in this FDA 510(k) record. The listed applicant is Tracoe Medical GmbH. It received FDA 510(k) clearance on 2016-12-21 under 510(k) 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. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K152778.

When did TRACOE Cuff Pressure Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for TRACOE Cuff Pressure Monitor?

The FDA 510(k) record lists Tracoe Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Tracoe Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203362TRACOE varioK172720TRACOE silcosoft Tracheostomy TubeK152865TRACOE smart Cuff Manager

Related Devices (Code: BSK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243562CuffGuardIdmedK242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies ApsK221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLCK192611CuffixBiovo Technologies , 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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