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FDA 510(k)

THERMOFLO HCH, THERMOFLO FILTER

K-Number: K090738 · 2009-07-27

ApplicantArc Medical, Inc.
Decision Date2009-07-27
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERMOFLO HCH, THERMOFLO FILTER 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 2009-07-27 under 510(k) number K090738. 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 THERMOFLO HCH, THERMOFLO FILTER?

THERMOFLO HCH, THERMOFLO FILTER is a medical device that received FDA 510(k) clearance on 2009-07-27. The listed applicant is Arc Medical, Inc.. The 510(k) number is K090738.

When did THERMOFLO HCH, THERMOFLO FILTER receive FDA 510(k) clearance?

THERMOFLO HCH, THERMOFLO FILTER received FDA 510(k) clearance on 2009-07-27, under 510(k) number K090738.

Who is the listed applicant for THERMOFLO HCH, THERMOFLO FILTER?

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 THERMOFLO HCH, THERMOFLO FILTER?

The FDA product code for THERMOFLO HCH, THERMOFLO FILTER 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.

K063125FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)K011212FILTERFLO 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

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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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