MASK, BI FLO NASAL OXYGEN— 510(k) K781741

Name: FDA 510(k) clearance K781741
Creator: U.S. Food and Drug Administration
Published: 1978-12-01

Substantially Equivalent

Inhal-O-Tech Medical Plastic

FDA 510(k) clearance K781741 for MASK, BI FLO NASAL OXYGEN, Substantially Equivalent on 1978-12-01. Applicant: Inhal-O-Tech Medical Plastic. Device class: 1.

Clearance details

Applicant: Inhal-O-Tech Medical Plastic
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1978-10-07
Decision date: 1978-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYG

view all

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 Inhal-O-Tech Medical Plastic

view all

K781394 — DISPOSABLE INCENTIVE SPIROMETER1978-10-16
K781395 — DISPOSABLE AEROSOL T BRIGGS ADAPTOR1978-08-31
K770353 — DISPOSABLE TEMPERATURE PROBE1977-03-16
K770354 — TUBING, AEROSAL, DISPOSABLE1977-03-16
K760329 — MASK, DISPOSABLE OXYGEN THERAPY1976-09-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.