Home / 510(k) Clearances / K931952

510(k) K931952

MEDWAY OXYGEN MASK by Medway — Product Code BYG

K931952 is an FDA 510(k) premarket notification submitted by Medway for the device "MEDWAY OXYGEN MASK". The FDA issued a decision of Substantially Equivalent on August 20, 1993. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Medway has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1993
Date Received
April 20, 1993
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 Medway

  • K934344 — HOME AMB-ALERT (April 29, 1994)
  • K911251 — FLEX-IV (October 28, 1991)
  • K911079 — AMB-ALERT (September 13, 1991)
  • K910880 — COMFOR-BOARD (June 6, 1991)

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)
  • K924069 — SURGICO OXYGEN MASK (February 4, 1993)

FDA data resources