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510(k) K852623

OXY-ONE by Ashai Co. , Ltd. — Product Code BYG

K852623 is an FDA 510(k) premarket notification submitted by Ashai Co. , Ltd. for the device "OXY-ONE". The FDA issued a decision of Substantially Equivalent on September 18, 1985. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Ashai Co. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1985
Date Received
June 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type

Other clearances by Ashai Co. , Ltd.

  • K870428 — AEROSOL ONE, NEBULIZER PUMP (May 15, 1987)
  • K852622 — AEROSOL ONE (April 24, 1986)
  • K852620 — SAFE.N.SURE (October 31, 1985)
  • K852627 — MAXI-NEB (September 26, 1985)
  • K852629 — AERO-MASK TWO (September 18, 1985)
  • K852626 — AERO-MASK ONE (September 18, 1985)
  • K852628 — NASAL ONE (September 18, 1985)
  • K852618 — OXY-DIAL (September 18, 1985)
  • K852624 — OXY-TWO (September 18, 1985)
  • K852625 — OXY-TUBE (September 18, 1985)

Other clearances for product code BYG

  • K963298 — FIRST AID KIT(S) (November 6, 1996)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K945482 — DISPOSABLE, CPAP OXYGEN MASK (September 19, 1995)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)
  • K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (September 15, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K942907 — JEMSDAL MASK (August 31, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)

FDA data resources