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FDA 510(k)

TRACOE smart Cuff Manager

K-Number: K152865 · 2016-09-27

ApplicantTracoe Medical GmbH
Decision Date2016-09-27
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACOE smart Cuff Manager 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 2016-09-27 under 510(k) number K152865. 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 smart Cuff Manager?

TRACOE smart Cuff Manager is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Tracoe Medical GmbH. The 510(k) number is K152865.

When did TRACOE smart Cuff Manager receive FDA 510(k) clearance?

TRACOE smart Cuff Manager received FDA 510(k) clearance on 2016-09-27, under 510(k) number K152865.

Who is the listed applicant for TRACOE smart Cuff Manager?

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 smart Cuff Manager?

The FDA product code for TRACOE smart Cuff Manager 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 TubeK152778TRACOE Cuff Pressure Monitor

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.

K261499TrachFlushAw Technologies ApsK243562CuffGuardIdmedK242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies ApsK221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC

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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