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510(k) K953039

VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS by Dadsun Corp., Ltd. — Product Code BYG

K953039 is an FDA 510(k) premarket notification submitted by Dadsun Corp., Ltd. for the device "VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Dadsun Corp., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
June 13, 1995
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 Dadsun Corp., Ltd.

  • K894457 — CARNATION TRACHEOSTOMY MASKS (October 13, 1989)
  • K851466 — CARNATION - OXYGEN MASK (June 19, 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)
  • 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)
  • K924069 — SURGICO OXYGEN MASK (February 4, 1993)

FDA data resources