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FDA 510(k)

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS

K-Number: K082009 · 2008-08-22

ApplicantHsiner Co., Ltd.
Decision Date2008-08-22
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS is the device name listed in this FDA 510(k) record. The listed applicant is Hsiner Co., Ltd.. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K082009. 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 HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS?

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Hsiner Co., Ltd.. The 510(k) number is K082009.

When did HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS receive FDA 510(k) clearance?

HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS received FDA 510(k) clearance on 2008-08-22, under 510(k) number K082009.

Who is the listed applicant for HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS?

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

What is the FDA product code for HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS?

The FDA product code for HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS is CAF.

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Other records listing Hsiner 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.

K251888VPAP Pediatric Face MaskK102120NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202K09118570530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTERK063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235K053466HSINER RESUSCITATORK052811HSINER JET NEBULIZER, MODEL HS-31100

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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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