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FDA 510(k)

70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER

K-Number: K091185 · 2009-07-24

ApplicantHsiner Co., Ltd.
Decision Date2009-07-24
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER 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 2009-07-24 under 510(k) number K091185. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER?

70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Hsiner Co., Ltd.. The 510(k) number is K091185.

When did 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER receive FDA 510(k) clearance?

70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER received FDA 510(k) clearance on 2009-07-24, under 510(k) number K091185.

Who is the listed applicant for 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER?

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 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER?

The FDA product code for 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER is CAH.

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Other records listing Hsiner Co., Ltd. as applicant

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K251888VPAP Pediatric Face MaskK102120NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202K082009HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDSK063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235K053466HSINER RESUSCITATORK052811HSINER JET NEBULIZER, MODEL HS-31100

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Related Devices (Code: CAH)

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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK241339Besmed Bacterial Filter and HMEFBesmed Health Business CorpK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , 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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