Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HSINER JET NEBULIZER, MODEL HS-31100

K-Number: K052811 · 2005-12-21

ApplicantHsiner Co., Ltd.
Decision Date2005-12-21
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HSINER JET NEBULIZER, MODEL HS-31100 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 2005-12-21 under 510(k) number K052811. 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 JET NEBULIZER, MODEL HS-31100?

HSINER JET NEBULIZER, MODEL HS-31100 is a medical device that received FDA 510(k) clearance on 2005-12-21. The listed applicant is Hsiner Co., Ltd.. The 510(k) number is K052811.

When did HSINER JET NEBULIZER, MODEL HS-31100 receive FDA 510(k) clearance?

HSINER JET NEBULIZER, MODEL HS-31100 received FDA 510(k) clearance on 2005-12-21, under 510(k) number K052811.

Who is the listed applicant for HSINER JET NEBULIZER, MODEL HS-31100?

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 JET NEBULIZER, MODEL HS-31100?

The FDA product code for HSINER JET NEBULIZER, MODEL HS-31100 is CAF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 FILTERK082009HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDSK063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235K053466HSINER RESUSCITATOR

View all 7 devices →

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.

↑