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FDA 510(k)

BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER

K-Number: K934540 · 1993-10-19

ApplicantBird Life Design
Decision Date1993-10-19
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER 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 1993-10-19 under 510(k) number K934540. 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-PF PULMONARY FUNCTION TESTING FILTER?

BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER is a medical device that received FDA 510(k) clearance on 1993-10-19. The listed applicant is Bird Life Design. The 510(k) number is K934540.

When did BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER receive FDA 510(k) clearance?

BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER received FDA 510(k) clearance on 1993-10-19, under 510(k) number K934540.

Who is the listed applicant for BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER?

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-PF PULMONARY FUNCTION TESTING FILTER?

The FDA product code for BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER 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 VALVEK934189BARRIERFLEX-I, AND BARRIERFLES-IIK934190HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATIONK933641BLD 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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