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FDA 510(k)

TRACOE vario

K-Number: K203362 · 2021-08-05

ApplicantTracoe Medical GmbH
Decision Date2021-08-05
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACOE vario is a medical device manufactured by Tracoe Medical GmbH. It received FDA 510(k) clearance on 2021-08-05 under approval number K203362. 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 vario?

TRACOE vario is a medical device that received FDA 510(k) clearance on 2021-08-05. It is manufactured by Tracoe Medical GmbH. The 510(k) number is K203362.

When was TRACOE vario approved by the FDA?

TRACOE vario received FDA 510(k) clearance on 2021-08-05, under approval number K203362.

What company makes TRACOE vario?

TRACOE vario is manufactured by Tracoe Medical GmbH.

What is the FDA product code for TRACOE vario?

The FDA product code for TRACOE vario is JOH.

Other Devices by Tracoe Medical GmbH

K152778TRACOE Cuff Pressure Monitor K152865TRACOE smart Cuff Manager K172720TRACOE silcosoft Tracheostomy Tube

Related Devices (Code: JOH)

K151404ProTrach DualcareAtos Medical AB K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc. K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tubeSmiths Medical Asd, Inc. K180034Weinmann Tracheostomy Exchange SetCook Incorporated K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbH K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange SetCook Incorporated

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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