SLEEPAP MASK— 510(k) K894642

Substantially Equivalent

Medical Industries America, Inc.

FDA 510(k) clearance K894642 for SLEEPAP MASK, Substantially Equivalent on 1989-10-19. Applicant: Medical Industries America, Inc.. Device class: 1.

Clearance details

Applicant: Medical Industries America, Inc.
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1989-07-24
Decision date: 1989-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Des Moines, IA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYG

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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

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K011053 — OPTIMA2001-04-20
K964078 — 3050 SPORT-NEB1997-01-10

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