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FDA 510(k)

DRUG NEBULIZERS

K-Number: K911422 · 1991-10-23

ApplicantIntersurgical, Inc.
Decision Date1991-10-23
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DRUG NEBULIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical, Inc.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K911422. 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 DRUG NEBULIZERS?

DRUG NEBULIZERS is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Intersurgical, Inc.. The 510(k) number is K911422.

When did DRUG NEBULIZERS receive FDA 510(k) clearance?

DRUG NEBULIZERS received FDA 510(k) clearance on 1991-10-23, under 510(k) number K911422.

Who is the listed applicant for DRUG NEBULIZERS?

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

What is the FDA product code for DRUG NEBULIZERS?

The FDA product code for DRUG NEBULIZERS is CAF.

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Other records listing Intersurgical, 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.

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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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