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FDA 510(k)

HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER

K-Number: K121770 · 2013-04-17

ApplicantHeadstar Medical Products Co., Ltd.
Decision Date2013-04-17
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Headstar Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2013-04-17 under 510(k) number K121770. 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 HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER?

HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER is a medical device that received FDA 510(k) clearance on 2013-04-17. The listed applicant is Headstar Medical Products Co., Ltd.. The 510(k) number is K121770.

When did HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER receive FDA 510(k) clearance?

HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER received FDA 510(k) clearance on 2013-04-17, under 510(k) number K121770.

Who is the listed applicant for HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER?

The FDA 510(k) record lists Headstar Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER?

The FDA product code for HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER is CAF.

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Other records listing Headstar Medical Products Co., Ltd. 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.

K002846HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR

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

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