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FDA 510(k)

AEROCHAMBER PLUS VALVED HOLDING CHAMBER

K-Number: K992917 · 1999-09-14

ApplicantTrudell Medical Int'L
Decision Date1999-09-14
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROCHAMBER PLUS VALVED HOLDING CHAMBER 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 1999-09-14 under 510(k) number K992917. 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 AEROCHAMBER PLUS VALVED HOLDING CHAMBER?

AEROCHAMBER PLUS VALVED HOLDING CHAMBER is a medical device that received FDA 510(k) clearance on 1999-09-14. The listed applicant is Trudell Medical Int'L. The 510(k) number is K992917.

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

AEROCHAMBER PLUS VALVED HOLDING CHAMBER received FDA 510(k) clearance on 1999-09-14, under 510(k) number K992917.

Who is the listed applicant for AEROCHAMBER PLUS VALVED HOLDING CHAMBER?

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 AEROCHAMBER PLUS VALVED HOLDING CHAMBER?

The FDA product code for AEROCHAMBER PLUS VALVED HOLDING CHAMBER is CAF.

Related Clinical Trials

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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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.

K001137AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

Official Source

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