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FDA 510(k)

TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER

K-Number: K982179 · 1998-09-17

ApplicantTrudell Medical
Decision Date1998-09-17
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical. It received FDA 510(k) clearance on 1998-09-17 under 510(k) number K982179. 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 TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER?

TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER is a medical device that received FDA 510(k) clearance on 1998-09-17. The listed applicant is Trudell Medical. The 510(k) number is K982179.

When did TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER receive FDA 510(k) clearance?

TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER received FDA 510(k) clearance on 1998-09-17, under 510(k) number K982179.

Who is the listed applicant for TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER?

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

What is the FDA product code for TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER?

The FDA product code for TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER is CAF.

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Other records listing Trudell Medical 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.

K982181TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZERK890010CM 7000MR

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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