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FDA 510(k)

TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER

K-Number: K982181 · 1999-01-08

ApplicantTrudell Medical
Decision Date1999-01-08
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRUMIST BREATH ACTUATED 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 1999-01-08 under 510(k) number K982181. 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 BREATH ACTUATED DISPOSABLE NEBULIZER?

TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER is a medical device that received FDA 510(k) clearance on 1999-01-08. The listed applicant is Trudell Medical. The 510(k) number is K982181.

When did TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER receive FDA 510(k) clearance?

TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER received FDA 510(k) clearance on 1999-01-08, under 510(k) number K982181.

Who is the listed applicant for TRUMIST BREATH ACTUATED 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 BREATH ACTUATED DISPOSABLE NEBULIZER?

The FDA product code for TRUMIST BREATH ACTUATED 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.

K982179TRUMIST AIR ENTRAINED 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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