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FDA 510(k)

THE SWIRLER AEROSOL SYSTEM

K-Number: K952893 · 1995-11-03

ApplicantAmici, Inc.
Decision Date1995-11-03
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE SWIRLER AEROSOL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amici, Inc.. It received FDA 510(k) clearance on 1995-11-03 under 510(k) number K952893. 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 THE SWIRLER AEROSOL SYSTEM?

THE SWIRLER AEROSOL SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-03. The listed applicant is Amici, Inc.. The 510(k) number is K952893.

When did THE SWIRLER AEROSOL SYSTEM receive FDA 510(k) clearance?

THE SWIRLER AEROSOL SYSTEM received FDA 510(k) clearance on 1995-11-03, under 510(k) number K952893.

Who is the listed applicant for THE SWIRLER AEROSOL SYSTEM?

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

What is the FDA product code for THE SWIRLER AEROSOL SYSTEM?

The FDA product code for THE SWIRLER AEROSOL SYSTEM is CAF.

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Other records listing Amici, 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.

K063716AEROSOL SYSTEMK952910THE SWIRLER NEBULIZERK903805AMICI XENON ADMINISTRATION SETK904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONK903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEK872920AMICI KRYPTON ADMINISTRATION SYSTEM*

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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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