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FDA 510(k)

HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION

K-Number: K934190 · 1993-11-24

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

Device Summary

HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION 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 K934190. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION?

HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION 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 K934190.

When did HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION receive FDA 510(k) clearance?

HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION received FDA 510(k) clearance on 1993-11-24, under 510(k) number K934190.

Who is the listed applicant for HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION?

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 HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION?

The FDA product code for HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION is BYD.

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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-IIK934540BARRIERFLEX-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: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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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