FDA 510(k)

ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))

K-Number: K121028 · 2012-06-21

Decision Date2012-06-21

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) is the device name listed in this FDA 510(k) record. The listed applicant is Etview , Ltd.. It received FDA 510(k) clearance on 2012-06-21 under 510(k) number K121028. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))?

ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) is a medical device that received FDA 510(k) clearance on 2012-06-21. The listed applicant is Etview , Ltd.. The 510(k) number is K121028.

When did ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) receive FDA 510(k) clearance?

ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) received FDA 510(k) clearance on 2012-06-21, under 510(k) number K121028.

Who is the listed applicant for ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))?

The FDA 510(k) record lists Etview , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))?

The FDA product code for ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) is BTR.

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Other records listing Etview , Ltd. as applicant

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Related Devices (Code: BTR)

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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.