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FDA 510(k)

AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

K-Number: K001137 · 2000-07-05

ApplicantTrudell Medical Int'L
Decision Date2000-07-05
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical Int'L. It received FDA 510(k) clearance on 2000-07-05 under 510(k) number K001137. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)?

AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) is a medical device that received FDA 510(k) clearance on 2000-07-05. The listed applicant is Trudell Medical Int'L. The 510(k) number is K001137.

When did AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) receive FDA 510(k) clearance?

AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) received FDA 510(k) clearance on 2000-07-05, under 510(k) number K001137.

Who is the listed applicant for AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)?

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

What is the FDA product code for AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)?

The FDA product code for AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) is CAF.

Related Clinical Trials

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Other records listing Trudell Medical Int'L 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.

K992917AEROCHAMBER PLUS VALVED HOLDING CHAMBER

Related Devices (Code: CAF)

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.

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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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