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510(k) K933048

LAERDAL(TM) POCKET MASK, MODIFICATION by Laerdal Medical Corp. — Product Code KGB

K933048 is an FDA 510(k) premarket notification submitted by Laerdal Medical Corp. for the device "LAERDAL(TM) POCKET MASK, MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 2, 1993. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570. Laerdal Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1993
Date Received
May 11, 1993
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 Laerdal Medical Corp.

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K232111 — NeoBeat, NeoBeat Mini (June 25, 2024)
  • K183348 — Reusable Silicone Cover CPRmeter 2 (December 17, 2018)
  • K173886 — CPRmeter 2 CPR Feedback Device (March 23, 2018)
  • K151702 — Reusable Full Silicone Cover (August 13, 2015)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
  • K023805 — LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 (February 11, 2003)
  • K001742 — RESUSCI INFLATE-A-SHIELD CPR BARRIER (October 6, 2000)
  • K993668 — LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 (December 20, 1999)

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)
  • 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)
  • K790162 — OXYGEN MASK, CONCENTRATION AEROSOL MASK (April 20, 1979)

FDA data resources