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510(k) K924069

SURGICO OXYGEN MASK by Gujarat Surgico, Ltd. — Product Code BYG

K924069 is an FDA 510(k) premarket notification submitted by Gujarat Surgico, Ltd. for the device "SURGICO OXYGEN MASK". The FDA issued a decision of Substantially Equivalent on February 4, 1993. 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
February 4, 1993
Date Received
August 11, 1992
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

  • 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)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)

FDA data resources