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510(k) K953464

WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK by Westmed, Inc. — Product Code BYG

K953464 is an FDA 510(k) premarket notification submitted by Westmed, Inc. for the device "WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK". The FDA issued a decision of Substantially Equivalent on September 18, 1995. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Westmed, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1995
Date Received
July 24, 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 Westmed, Inc.

  • K162343 — Westmed Gas Sampling Cannula with O2 delivery (December 14, 2016)
  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K133057 — VIBRALUNG ACOUSTICAL PERCUSSOR (May 23, 2014)
  • K121382 — WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] (December 6, 2012)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K072220 — PEDI CO2 EASY (August 23, 2007)
  • K070128 — CO2 EASY (February 15, 2007)

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)
  • 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)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)
  • K924069 — SURGICO OXYGEN MASK (February 4, 1993)

FDA data resources