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FDA 510(k)

FILTER-FLEX

K-Number: K841236 · 1984-04-05

ApplicantLife Design Systems, Inc.
Decision Date1984-04-05
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FILTER-FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K841236. 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-FLEX?

FILTER-FLEX is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K841236.

When did FILTER-FLEX receive FDA 510(k) clearance?

FILTER-FLEX received FDA 510(k) clearance on 1984-04-05, under 510(k) number K841236.

Who is the listed applicant for FILTER-FLEX?

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

What is the FDA product code for FILTER-FLEX?

The FDA product code for FILTER-FLEX is CAH.

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Other records listing Life Design Systems, 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.

K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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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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