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FDA 510(k)

SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN

K-Number: K834077 · 1983-12-12

ApplicantAirlife, Inc.
Decision Date1983-12-12
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1983-12-12 under 510(k) number K834077. 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 SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN?

SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Airlife, Inc.. The 510(k) number is K834077.

When did SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN receive FDA 510(k) clearance?

SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN received FDA 510(k) clearance on 1983-12-12, under 510(k) number K834077.

Who is the listed applicant for SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN?

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

What is the FDA product code for SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN?

The FDA product code for SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN is CAF.

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Other records listing Airlife, Inc. as applicant

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K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASKK831246WHISTLER IN-LINE PRESSURE RELEASE VALVE

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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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