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510(k) K940888

SYSTEM 22 PAEDIATRIC MASK by Medic-Aid , Ltd. — Product Code BYG

K940888 is an FDA 510(k) premarket notification submitted by Medic-Aid , Ltd. for the device "SYSTEM 22 PAEDIATRIC MASK". The FDA issued a decision of Substantially Equivalent on April 19, 1994. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Medic-Aid , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1994
Date Received
February 25, 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 Medic-Aid , Ltd.

  • K991685 — HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR (August 13, 1999)
  • K981772 — HALOLITE AAD SYSTEM (November 3, 1998)
  • K971933 — PORT-NEB (August 1, 1997)
  • K934749 — FREEWAY LITE NEBULIZER COMPRESSOR (July 25, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K933535 — VENTSTREAM DRUG NEBULIZER (January 24, 1994)
  • K924123 — SIDESTREAM DISPOSABLE (November 16, 1992)
  • K914152 — SIDESTREAM DRUG NEBULIZER (May 5, 1992)

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)
  • 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