FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K860106 |
AMERICAN BENTLEY |
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 |
02/26/1986 |
K853786 |
AMERICAN BENTLEY |
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 |
10/16/1985 |
K872896 |
AMERICAN BENTLEY |
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 |
02/12/1988 |
K890624 |
BAXTER HEALTHCARE CORP. |
TISSUE OXYGEN MONITOR SYSTEM, MODEL II |
12/22/1989 |
K910453 |
BAXTER HEALTHCARE CORP. |
TOPS NEEDLE TIP PROBE & PVC TIP PROBE |
08/13/1991 |
K884063 |
C.R. BARD, INC. |
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM |
12/16/1988 |
K872125 |
C.R. BARD, INC. |
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM |
12/11/1987 |
K843912 |
CARDIOVASCULAR DEVICES, INC. |
INTRAVASCULAR BLOOD GAS SYSTEM |
01/10/1985 |
K811071 |
G.D. SEARLE AND CO. |
VENOUS OXYGEN PROBE |
05/05/1981 |
K840102 |
M. D. SOFTWARE, INC. |
ARTERIAL BLOOD GAS INTERPRETATION PROG |
02/04/1984 |
K875225 |
OHMEDA MEDICAL |
UMBILICAL ARTERY OXYGEN SENSOR |
03/04/1988 |
K896311 |
OPTEX BIOMEDICAL |
OPTEX BLOOD GAS MONITORING SYSTEM |
01/03/1990 |
K860808 |
ORANGE MEDICAL INSTRUMENTS, INC. |
CONTINUCATH |
03/13/1986 |
K832793 |
ORANGE MEDICAL INSTRUMENTS, INC. |
NEOCATH 1000 W/HEPCOTE |
09/26/1983 |
K905397 |
PURITAN BENNETT CORP. |
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM |
05/14/1991 |
K781271 |
ROCHE MEDICAL ELECTRONICS, INC. |
MONITOR, PO2, INTRAVASCULAR |
10/12/1978 |
K912145 |
S & W MEDICO TEKNIK |
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA |
05/05/1992 |
K771116 |
SHERWOOD MEDICAL INDUSTRIES |
CATHETER, PO2, INTRAVASUCLAR, CITADEL |
09/15/1977 |
K760350 |
SHERWOOD MEDICAL INDUSTRIES |
MONITOR, CITADEL INTRAVASCULAR PO2 |
10/29/1976 |
K895150 |
SHILEY, INC. |
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING |
11/28/1989 |
K895149 |
SHILEY, INC. |
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY |
11/28/1989 |
K935778 |
VIA MEDICAL CORP. |
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM |
12/05/1996 |
K780850 |
WILL ROSS CO. |
SEARLE NEONATAL OXYGEN PROBE |
08/23/1978 |