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510(k) K781414

MASK, OXYGEN, NONBREATHING by Vitalab Products Corp. — Product Code KGB

K781414 is an FDA 510(k) premarket notification submitted by Vitalab Products Corp. for the device "MASK, OXYGEN, NONBREATHING". The FDA issued a decision of Substantially Equivalent on September 7, 1978. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570. Vitalab Products Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1978
Date Received
August 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Non-Rebreathing
Device Class
Class I
Regulation Number
868.5570
Review Panel
AN
Submission Type

Other clearances by Vitalab Products Corp.

  • K781416 — TUBING, FLEXIBLE, MEDICAL GAS (September 11, 1978)
  • K781413 — MASK, PXYGEN (September 7, 1978)
  • K781415 — CANNULA, NASAL, OXYGEN (September 7, 1978)

Other clearances for product code KGB

  • K970688 — POCKET RESCUE (September 26, 1997)
  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K941336 — COMBO MASK (September 9, 1994)
  • K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES (February 4, 1994)
  • K932347 — COMPACT MASK (January 10, 1994)
  • K933583 — NONREBREATHING VALVE (January 3, 1994)
  • K933048 — LAERDAL(TM) POCKET MASK, MODIFICATION (December 2, 1993)
  • K930336 — PROFAST(R)-DENTURE ADHESIVE CREAM (August 24, 1993)
  • K913164 — NON REBREATHING MASK (January 15, 1992)
  • K883766 — MOUTH-TO-MASK VENTILATORY ADJUNCT (October 21, 1988)

FDA data resources