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FDA 510(k)

AIR SAFETY HEPA AND NON-HEPA FILTERS

K-Number: K033008 · 2004-05-13

ApplicantAir Safety, Ltd.
Decision Date2004-05-13
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR SAFETY HEPA AND NON-HEPA FILTERS is the device name listed in this FDA 510(k) record. The listed applicant is Air Safety, Ltd.. It received FDA 510(k) clearance on 2004-05-13 under 510(k) number K033008. 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 AIR SAFETY HEPA AND NON-HEPA FILTERS?

AIR SAFETY HEPA AND NON-HEPA FILTERS is a medical device that received FDA 510(k) clearance on 2004-05-13. The listed applicant is Air Safety, Ltd.. The 510(k) number is K033008.

When did AIR SAFETY HEPA AND NON-HEPA FILTERS receive FDA 510(k) clearance?

AIR SAFETY HEPA AND NON-HEPA FILTERS received FDA 510(k) clearance on 2004-05-13, under 510(k) number K033008.

Who is the listed applicant for AIR SAFETY HEPA AND NON-HEPA FILTERS?

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

What is the FDA product code for AIR SAFETY HEPA AND NON-HEPA FILTERS?

The FDA product code for AIR SAFETY HEPA AND NON-HEPA FILTERS is CAH.

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 Air Safety, 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.

K051712MODEL 2800 PFT FILTERK050953AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLEK040712AIR SAFETY HEPA, MODEL 3500

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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