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FDA 510(k)

FILTER

K-Number: K970102 · 1997-06-24

ApplicantPromedic, Inc.
Decision Date1997-06-24
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Promedic, Inc.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K970102. 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 FILTER?

FILTER is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Promedic, Inc.. The 510(k) number is K970102.

When did FILTER receive FDA 510(k) clearance?

FILTER received FDA 510(k) clearance on 1997-06-24, under 510(k) number K970102.

Who is the listed applicant for FILTER?

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

What is the FDA product code for FILTER?

The FDA product code for 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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Related PubMed Literature

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.

PMID: 39556835Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.Annals of internal medicine ()

Other records listing Promedic, 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.

K112318CLEARPATH 24K072756NON-IV ADAPTER FOR INFANT NG TUBEK060497BABYAIRK060842REVJET TURBOK052903PEDIATRIC FEEDING TUBEK031409URINARY CATHETERS

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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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