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FDA 510(k)

BARRIERFLEX-I, AND BARRIERFLES-II

K-Number: K934189 · 1993-11-24

ApplicantBird Life Design
Decision Date1993-11-24
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BARRIERFLEX-I, AND BARRIERFLES-II is the device name listed in this FDA 510(k) record. The listed applicant is Bird Life Design. It received FDA 510(k) clearance on 1993-11-24 under 510(k) number K934189. 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 BARRIERFLEX-I, AND BARRIERFLES-II?

BARRIERFLEX-I, AND BARRIERFLES-II is a medical device that received FDA 510(k) clearance on 1993-11-24. The listed applicant is Bird Life Design. The 510(k) number is K934189.

When did BARRIERFLEX-I, AND BARRIERFLES-II receive FDA 510(k) clearance?

BARRIERFLEX-I, AND BARRIERFLES-II received FDA 510(k) clearance on 1993-11-24, under 510(k) number K934189.

Who is the listed applicant for BARRIERFLEX-I, AND BARRIERFLES-II?

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

What is the FDA product code for BARRIERFLEX-I, AND BARRIERFLES-II?

The FDA product code for BARRIERFLEX-I, AND BARRIERFLES-II is CAH.

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Other records listing Bird Life Design 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.

K931487BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVEK934190HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATIONK934540BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTERK933641BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLEK925543BLD-18000 SERIES HEATED BREATHING CIRCUITK930252BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)

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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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