PEDIATRIC OXYGEN OR AEROSOL MASKS,— 510(k) K802323

Name: FDA 510(k) clearance K802323
Creator: U.S. Food and Drug Administration
Published: 1980-10-03

Substantially Equivalent

Airlife, Inc.

FDA 510(k) clearance K802323 for PEDIATRIC OXYGEN OR AEROSOL MASKS,, Substantially Equivalent on 1980-10-03. Applicant: Airlife, Inc.. Device class: 1.

Clearance details

Applicant: Airlife, Inc.
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1980-09-23
Decision date: 1980-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYG

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K963298 — FIRST AID KIT(S)1996-11-06
K962848 — HANS RUDOLPH NASAL CPAP MASK1996-10-16
K945482 — DISPOSABLE, CPAP OXYGEN MASK1995-09-19
K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK1995-09-18
K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS1995-09-15

More clearances from Airlife, Inc.

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K834570 — VOLUME VENTILATOR CIRCUIT W/WATER TRAP1984-03-05
K834573 — AQUA TRAP1984-03-05
K834077 — SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN1983-12-12
K833196 — VOLUME VENTILATOR CIRCUIT-NEBULIZER1983-11-03
K833197 — TRACH SWIVE/CONNECTOR1983-10-28

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