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FDA 510(k)

FILTERFLO H

K-Number: K011212 · 2001-12-20

ApplicantArc Medical, Inc.
Decision Date2001-12-20
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FILTERFLO H is the device name listed in this FDA 510(k) record. The listed applicant is Arc Medical, Inc.. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K011212. 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 FILTERFLO H?

FILTERFLO H is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Arc Medical, Inc.. The 510(k) number is K011212.

When did FILTERFLO H receive FDA 510(k) clearance?

FILTERFLO H received FDA 510(k) clearance on 2001-12-20, under 510(k) number K011212.

Who is the listed applicant for FILTERFLO H?

The FDA 510(k) record lists Arc Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILTERFLO H?

The FDA product code for FILTERFLO H 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 Arc Medical, Inc. 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.

K090738THERMOFLO HCH, THERMOFLO FILTERK063125FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)K982239CIRCUIT GUARDK924997EDDK924627XTEND CIRCUITS (TM)

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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