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510(k) K963298

FIRST AID KIT(S) by Vector, Inc. — Product Code BYG

K963298 is an FDA 510(k) premarket notification submitted by Vector, Inc. for the device "FIRST AID KIT(S)". The FDA issued a decision of Substantially Equivalent on November 6, 1996. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1996
Date Received
August 21, 1996
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 for product code BYG

  • 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)
  • 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