HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION— 510(k) K934190

Name: FDA 510(k) clearance K934190
Creator: U.S. Food and Drug Administration
Published: 1993-11-24

Substantially Equivalent

Bird Life Design

FDA 510(k) clearance K934190 for HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION, Substantially Equivalent on 1993-11-24. Applicant: Bird Life Design. Device class: 1.

Clearance details

Applicant: Bird Life Design
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1993-08-26
Decision date: 1993-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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K953507 — TYPE 1 & 2 (HUMIDAIR I & II)1995-09-07
K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE1995-08-25

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K934540 — BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER1993-10-19
K933641 — BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE1993-10-15
K925543 — BLD-18000 SERIES HEATED BREATHING CIRCUIT1993-04-30

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