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FDA 510(k)

MYSTIQUE ULTRASONIC NEBULIZER

K-Number: K983002 · 1998-10-16

ApplicantAirsep Corp.
Decision Date1998-10-16
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MYSTIQUE ULTRASONIC NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K983002. 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 MYSTIQUE ULTRASONIC NEBULIZER?

MYSTIQUE ULTRASONIC NEBULIZER is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Airsep Corp.. The 510(k) number is K983002.

When did MYSTIQUE ULTRASONIC NEBULIZER receive FDA 510(k) clearance?

MYSTIQUE ULTRASONIC NEBULIZER received FDA 510(k) clearance on 1998-10-16, under 510(k) number K983002.

Who is the listed applicant for MYSTIQUE ULTRASONIC NEBULIZER?

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

What is the FDA product code for MYSTIQUE ULTRASONIC NEBULIZER?

The FDA product code for MYSTIQUE ULTRASONIC NEBULIZER is CAF.

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Other records listing Airsep Corp. 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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