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510(k) K945472

WESTMED PEDIATRIC AND ADULT AEROSOL MASK by Westmed Intl. — Product Code BYG

K945472 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "WESTMED PEDIATRIC AND ADULT AEROSOL MASK". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Westmed Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
November 8, 1994
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 Intl.

  • K955047 — WESTMED CIRCULARIE PEP DEVICES (March 27, 1996)
  • K954271 — WESTMED CONDESATE COLLECTION TRAP (December 28, 1995)
  • K952616 — MICROTIME (September 27, 1995)
  • K953687 — WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER (September 18, 1995)
  • K953506 — WESTMED RESPIRATORY LUER ADAPTOR (September 15, 1995)
  • K951484 — WESTMED BACTERIAL/VIRAL FILTER (April 24, 1995)
  • K924944 — INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA (July 2, 1993)
  • K925173 — BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT (January 15, 1993)

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)
  • 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