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510(k) K852618

OXY-DIAL by Ashai Co. , Ltd. — Product Code BYF

K852618 is an FDA 510(k) premarket notification submitted by Ashai Co. , Ltd. for the device "OXY-DIAL". The FDA issued a decision of Substantially Equivalent on September 18, 1985. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. 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, Low Concentration, Venturi
Device Class
Class I
Regulation Number
868.5600
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)
  • K852623 — OXY-ONE (September 18, 1985)
  • K852624 — OXY-TWO (September 18, 1985)
  • K852625 — OXY-TUBE (September 18, 1985)

Other clearances for product code BYF

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K951652 — VENTIMASK MK IV (April 27, 1995)
  • K894457 — CARNATION TRACHEOSTOMY MASKS (October 13, 1989)
  • K860873 — VENTURI MASK/ADULT & PAEDIATRIC (March 20, 1986)
  • K860874 — VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC (March 19, 1986)
  • K832725 — DUAL DIAL VENTURI STYLE MASK (September 20, 1983)
  • K812066 — PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (August 3, 1981)
  • K810947 — AIR ENTRAINMENT TRACH T (June 2, 1981)
  • K810946 — ADULT & PEDIATRIC TRACHEOSTOMY MASKS (June 2, 1981)
  • K810373 — VENTURI MASK/DELIVERY SYSTEM #'S (March 17, 1981)

FDA data resources