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FDA 510(k)

BACTERIA/VIRAL FILTER

K-Number: K961914 · 1996-08-14

ApplicantHudson Respiratory Care, Inc.
Decision Date1996-08-14
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BACTERIA/VIRAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Respiratory Care, Inc.. It received FDA 510(k) clearance on 1996-08-14 under 510(k) number K961914. 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 BACTERIA/VIRAL FILTER?

BACTERIA/VIRAL FILTER is a medical device that received FDA 510(k) clearance on 1996-08-14. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K961914.

When did BACTERIA/VIRAL FILTER receive FDA 510(k) clearance?

BACTERIA/VIRAL FILTER received FDA 510(k) clearance on 1996-08-14, under 510(k) number K961914.

Who is the listed applicant for BACTERIA/VIRAL FILTER?

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

What is the FDA product code for BACTERIA/VIRAL FILTER?

The FDA product code for BACTERIA/VIRAL FILTER is CAH.

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Other records listing Hudson Respiratory Care, 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.

K031383MODEL 780K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIK011134OXYGEN SUPPLY TUBING, MODEL 1115K010402SMOOTH-FLO CIRCUITK001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43

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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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