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FDA 510(k)

FLEXICARE BREATHING FILTERS

K-Number: K092218 · 2009-10-06

ApplicantFlexicare Medical, Ltd.
Decision Date2009-10-06
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXICARE BREATHING FILTERS is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical, Ltd.. It received FDA 510(k) clearance on 2009-10-06 under 510(k) number K092218. 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 FLEXICARE BREATHING FILTERS?

FLEXICARE BREATHING FILTERS is a medical device that received FDA 510(k) clearance on 2009-10-06. The listed applicant is Flexicare Medical, Ltd.. The 510(k) number is K092218.

When did FLEXICARE BREATHING FILTERS receive FDA 510(k) clearance?

FLEXICARE BREATHING FILTERS received FDA 510(k) clearance on 2009-10-06, under 510(k) number K092218.

Who is the listed applicant for FLEXICARE BREATHING FILTERS?

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

What is the FDA product code for FLEXICARE BREATHING FILTERS?

The FDA product code for FLEXICARE BREATHING 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.

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Other records listing Flexicare Medical, 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.

K132619CLASSIC INTERMITTENT CATHETERK091591FLEXICARE MEDICAL ENDOTRACHEAL TUBESK951652VENTIMASK MK IV

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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