OXY-DIAL— 510(k) K852618

Substantially Equivalent

Ashai Co. , Ltd.

FDA 510(k) clearance K852618 for OXY-DIAL, Substantially Equivalent on 1985-09-18. Applicant: Ashai Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Ashai Co. , Ltd.
Product code: Code BYF
Device class: Class 1
Regulation: 21 CFR 868.5600
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 ↗

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K894457 — CARNATION TRACHEOSTOMY MASKS1989-10-13
K860873 — VENTURI MASK/ADULT & PAEDIATRIC1986-03-20
K860874 — VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC1986-03-19

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
K852623 — OXY-ONE1985-09-18

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