DISPOSABLE, CPAP OXYGEN MASK— 510(k) K945482

Substantially Equivalent

Fvtnks

FDA 510(k) clearance K945482 for DISPOSABLE, CPAP OXYGEN MASK, Substantially Equivalent on 1995-09-19. Applicant: Fvtnks. Device class: 1.

Clearance details

Applicant: Fvtnks
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1994-11-08
Decision date: 1995-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturgis, MI, US

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Recent devices under product code BYG

K963298 — FIRST AID KIT(S)1996-11-06
K962848 — HANS RUDOLPH NASAL CPAP MASK1996-10-16
K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK1995-09-18
K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS1995-09-15
K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK1995-02-07

More clearances from Fvtnks

K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK1994-11-08
K940544 — DOUBLE TRACH SEIVEL CONNECTOR1994-04-19
K935713 — WILEY/ESPOSITO DENTAL GUARD1994-01-05

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