MASK, DISPOSABLE OXYGEN THERAPY— 510(k) K760329

Name: FDA 510(k) clearance K760329
Creator: U.S. Food and Drug Administration
Published: 1976-09-30

Substantially Equivalent

Inhal-O-Tech Medical Plastic

FDA 510(k) clearance K760329 for MASK, DISPOSABLE OXYGEN THERAPY, Substantially Equivalent on 1976-09-30. 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: 1976-07-28
Decision date: 1976-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, US

Download summary PDF View on FDA.gov ↗

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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

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K781741 — MASK, BI FLO NASAL OXYGEN1978-12-01
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

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