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FDA 510(k)

AEROCHAMBER MINI VENTILATION CHAMBER

K-Number: K090065 · 2009-04-09

ApplicantTrudell Medical Intl.
Decision Date2009-04-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROCHAMBER MINI VENTILATION CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical Intl.. It received FDA 510(k) clearance on 2009-04-09 under 510(k) number K090065. 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 MINI VENTILATION CHAMBER?

AEROCHAMBER MINI VENTILATION CHAMBER is a medical device that received FDA 510(k) clearance on 2009-04-09. The listed applicant is Trudell Medical Intl.. The 510(k) number is K090065.

When did AEROCHAMBER MINI VENTILATION CHAMBER receive FDA 510(k) clearance?

AEROCHAMBER MINI VENTILATION CHAMBER received FDA 510(k) clearance on 2009-04-09, under 510(k) number K090065.

Who is the listed applicant for AEROCHAMBER MINI VENTILATION CHAMBER?

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

What is the FDA product code for AEROCHAMBER MINI VENTILATION CHAMBER?

The FDA product code for AEROCHAMBER MINI VENTILATION CHAMBER is CAF.

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Other records listing Trudell Medical Intl. 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.

K131881OMBRA TABLE TOP COMPRESSORK123400AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICEK123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)K112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)K110136RESPICHAMBER VALVED HOLDING CHAMBERK080926AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER

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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

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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