Product code KGB— Anesthesiology

FDA has cleared 13 devices under product code KGB between 1978 and 1997, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19971 clearance
• 19961 clearance
• 19944 clearances
• 19932 clearances
• 19921 clearance
• 19881 clearance
• 19792 clearances
• 19781 clearance

• Hans Rudolph, Inc.2 clearances
• Airlife, Inc.2 clearances
• Vitalab Products Corp.1 clearance
• Vital Signs, Inc.1 clearance
• Specialty Packaging Producs, Inc.1 clearance
• Medic One1 clearance
• Laerdal Medical Corp.1 clearance
• Gam Industries, Inc.1 clearance
• Fittydent-Altwirth & Schmitt GmbH1 clearance
• Cheen Houng Ent. Co. , Ltd.1 clearance

• K970688 — POCKET RESCUECheen Houng Ent. Co. , Ltd.·1997-09-26
• K960401 — ULTIMATE SEALHans Rudolph, Inc.·1996-06-20
• K941336 — COMBO MASKGam Industries, Inc.·1994-09-09
• K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems Preanalytic·1994-02-04
• K932347 — COMPACT MASKVital Signs, Inc.·1994-01-10
• K933583 — NONREBREATHING VALVEHans Rudolph, Inc.·1994-01-03
• K933048 — LAERDAL(TM) POCKET MASK, MODIFICATIONLaerdal Medical Corp.·1993-12-02
• K930336 — PROFAST(R)-DENTURE ADHESIVE CREAMFittydent-Altwirth & Schmitt GmbH·1993-08-24
• K913164 — NON REBREATHING MASKSpecialty Packaging Producs, Inc.·1992-01-15
• K883766 — MOUTH-TO-MASK VENTILATORY ADJUNCTMedic One·1988-10-21
• K790161 — OXYGEN MASK W/RESERVOIR BAGAirlife, Inc.·1979-04-20
• K790162 — OXYGEN MASK, CONCENTRATION AEROSOL MASKAirlife, Inc.·1979-04-20
• K781414 — MASK, OXYGEN, NONBREATHINGVitalab Products Corp.·1978-09-07