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FDA 510(k)

AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE

K-Number: K050953 · 2005-06-29

ApplicantAir Safety, Ltd.
Decision Date2005-06-29
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE 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 2005-06-29 under 510(k) number K050953. 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 MODEL 3000/06 FILTER HEPA REUSABLE?

AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE is a medical device that received FDA 510(k) clearance on 2005-06-29. The listed applicant is Air Safety, Ltd.. The 510(k) number is K050953.

When did AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE receive FDA 510(k) clearance?

AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE received FDA 510(k) clearance on 2005-06-29, under 510(k) number K050953.

Who is the listed applicant for AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE?

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 MODEL 3000/06 FILTER HEPA REUSABLE?

The FDA product code for AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE 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.

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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 FILTERK040712AIR SAFETY HEPA, MODEL 3500K033008AIR SAFETY HEPA AND NON-HEPA FILTERS

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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