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FDA 510(k)

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)

K-Number: K063125 · 2007-04-13

ApplicantArc Medical, Inc.
Decision Date2007-04-13
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) 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 2007-04-13 under 510(k) number K063125. 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 HEPA; THERMOFLO HEPA (FILTER / HME)?

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Arc Medical, Inc.. The 510(k) number is K063125.

When did FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) receive FDA 510(k) clearance?

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) received FDA 510(k) clearance on 2007-04-13, under 510(k) number K063125.

Who is the listed applicant for FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)?

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 HEPA; THERMOFLO HEPA (FILTER / HME)?

The FDA product code for FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) 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 FILTERK011212FILTERFLO HK982239CIRCUIT 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

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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