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FDA 510(k)

TRACOE silcosoft Tracheostomy Tube

K-Number: K172720 · 2018-04-27

ApplicantTracoe Medical GmbH
Decision Date2018-04-27
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACOE silcosoft Tracheostomy Tube is a medical device manufactured by Tracoe Medical GmbH. It received FDA 510(k) clearance on 2018-04-27 under approval number K172720. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACOE silcosoft Tracheostomy Tube?

TRACOE silcosoft Tracheostomy Tube is a medical device that received FDA 510(k) clearance on 2018-04-27. It is manufactured by Tracoe Medical GmbH. The 510(k) number is K172720.

When was TRACOE silcosoft Tracheostomy Tube approved by the FDA?

TRACOE silcosoft Tracheostomy Tube received FDA 510(k) clearance on 2018-04-27, under approval number K172720.

What company makes TRACOE silcosoft Tracheostomy Tube?

TRACOE silcosoft Tracheostomy Tube is manufactured by Tracoe Medical GmbH.

What is the FDA product code for TRACOE silcosoft Tracheostomy Tube?

The FDA product code for TRACOE silcosoft Tracheostomy Tube is JOH.

Other Devices by Tracoe Medical GmbH

K152778TRACOE Cuff Pressure Monitor K152865TRACOE smart Cuff Manager K203362TRACOE vario

Related Devices (Code: JOH)

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Official Source

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

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