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FDA 510(k)

ULTRASONIC NEBULIZER (MESH TYPE)

K-Number: K121520 · 2013-03-15

ApplicantK-Jump Health Co., Ltd.
Decision Date2013-03-15
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC NEBULIZER (MESH TYPE) is the device name listed in this FDA 510(k) record. The listed applicant is K-Jump Health Co., Ltd.. It received FDA 510(k) clearance on 2013-03-15 under 510(k) number K121520. 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 ULTRASONIC NEBULIZER (MESH TYPE)?

ULTRASONIC NEBULIZER (MESH TYPE) is a medical device that received FDA 510(k) clearance on 2013-03-15. The listed applicant is K-Jump Health Co., Ltd.. The 510(k) number is K121520.

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

ULTRASONIC NEBULIZER (MESH TYPE) received FDA 510(k) clearance on 2013-03-15, under 510(k) number K121520.

Who is the listed applicant for ULTRASONIC NEBULIZER (MESH TYPE)?

The FDA 510(k) record lists K-Jump Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC NEBULIZER (MESH TYPE)?

The FDA product code for ULTRASONIC NEBULIZER (MESH TYPE) is CAF.

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Other records listing K-Jump Health Co., Ltd. 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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