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FDA 510(k)

TRACH-ASSIST

K-Number: K083702 · 2009-03-05

ApplicantMergenet Medical
Decision Date2009-03-05
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH-ASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Mergenet Medical. It received FDA 510(k) clearance on 2009-03-05 under 510(k) number K083702. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACH-ASSIST?

TRACH-ASSIST is a medical device that received FDA 510(k) clearance on 2009-03-05. The listed applicant is Mergenet Medical. The 510(k) number is K083702.

When did TRACH-ASSIST receive FDA 510(k) clearance?

TRACH-ASSIST received FDA 510(k) clearance on 2009-03-05, under 510(k) number K083702.

Who is the listed applicant for TRACH-ASSIST?

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

What is the FDA product code for TRACH-ASSIST?

The FDA product code for TRACH-ASSIST is BZA.

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Related Devices (Code: BZA)

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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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