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FDA 510(k)

AERO-GEN NEBULIZER

K-Number: K904716 · 1991-01-02

ApplicantTri/Bor Medical, Inc.
Decision Date1991-01-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AERO-GEN NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Tri/Bor Medical, Inc.. It received FDA 510(k) clearance on 1991-01-02 under 510(k) number K904716. 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 AERO-GEN NEBULIZER?

AERO-GEN NEBULIZER is a medical device that received FDA 510(k) clearance on 1991-01-02. The listed applicant is Tri/Bor Medical, Inc.. The 510(k) number is K904716.

When did AERO-GEN NEBULIZER receive FDA 510(k) clearance?

AERO-GEN NEBULIZER received FDA 510(k) clearance on 1991-01-02, under 510(k) number K904716.

Who is the listed applicant for AERO-GEN NEBULIZER?

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

What is the FDA product code for AERO-GEN NEBULIZER?

The FDA product code for AERO-GEN NEBULIZER is CAF.

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Other records listing Tri/Bor Medical, Inc. 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.

K904718AERO-GEN NUBULIZER SYSTEMK904717MICRO-VENT NEBULIZER SYSTEMK904715OXYGEN/AIR TUBINGK904719DISPOSABLE FACE MASK

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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