OXY-ONE— 510(k) K852623

Substantially Equivalent

Ashai Co. , Ltd.

FDA 510(k) clearance K852623 for OXY-ONE, Substantially Equivalent on 1985-09-18. Applicant: Ashai Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Ashai Co. , Ltd.
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1985-06-20
Decision date: 1985-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYG

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 Ashai Co. , Ltd.

K870428 — AEROSOL ONE, NEBULIZER PUMP1987-05-15
K852622 — AEROSOL ONE1986-04-24
K852620 — SAFE.N.SURE1985-10-31
K852627 — MAXI-NEB1985-09-26
K852618 — OXY-DIAL1985-09-18

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