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FDA 510(k)

AEROMIST II NEBULIZER

K-Number: K901315 · 1990-09-10

ApplicantInhalation Plastics
Decision Date1990-09-10
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROMIST II NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Inhalation Plastics. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K901315. 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 AEROMIST II NEBULIZER?

AEROMIST II NEBULIZER is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Inhalation Plastics. The 510(k) number is K901315.

When did AEROMIST II NEBULIZER receive FDA 510(k) clearance?

AEROMIST II NEBULIZER received FDA 510(k) clearance on 1990-09-10, under 510(k) number K901315.

Who is the listed applicant for AEROMIST II NEBULIZER?

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

What is the FDA product code for AEROMIST II NEBULIZER?

The FDA product code for AEROMIST II NEBULIZER is CAF.

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Other records listing Inhalation Plastics 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.

K945565SPIRO-FLEXK914686THERMO-FLOW SETK900990FILT-R-ALL BACTERIAL/VIRAL FILTERK900594ANESTHESIA BREATHING CIRCUITK896832FILT-R-ALL BACTERIAL FILTERK874659STERILIZATION OF DEVICES BY RADIATION

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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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