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510(k) K933583

NONREBREATHING VALVE by Hans Rudolph, Inc. — Product Code KGB

K933583 is an FDA 510(k) premarket notification submitted by Hans Rudolph, Inc. for the device "NONREBREATHING VALVE". The FDA issued a decision of Substantially Equivalent on January 3, 1994. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570. Hans Rudolph, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1994
Date Received
July 23, 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 Hans Rudolph, Inc.

  • K071149 — HRI 6500, 6600 AND 6700 SERIES V2MASKS (February 1, 2008)
  • K030822 — 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS (June 3, 2003)
  • K030515 — HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS (May 2, 2003)
  • K020759 — 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, (August 13, 2002)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K946077 — DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS (September 15, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)
  • K791705 — 4200 PNEUMATIC MOUTH SHUTTER (October 4, 1979)

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

FDA data resources