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FDA 510(k)

SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896

K-Number: K994352 · 2000-03-22

ApplicantHudson Respiratory Care, Inc.
Decision Date2000-03-22
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Respiratory Care, Inc.. It received FDA 510(k) clearance on 2000-03-22 under 510(k) number K994352. 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 SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896?

SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 is a medical device that received FDA 510(k) clearance on 2000-03-22. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K994352.

When did SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 receive FDA 510(k) clearance?

SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 received FDA 510(k) clearance on 2000-03-22, under 510(k) number K994352.

Who is the listed applicant for SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896?

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

What is the FDA product code for SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896?

The FDA product code for SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 is CAF.

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Other records listing Hudson Respiratory Care, Inc. as applicant

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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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