510(k) K860106
- Device
- OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
- Applicant
- AMERICAN BENTLEY
- 510(k) number
- K860106
- Product code
- CCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-26
- Date received
- 1986-01-13
- Regulation
- 868.1200
- Classification name
- Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD A RAIBLE
- Address
- P.O. Box 19522 Irvine CA US 92713 92713
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CCE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935778 | VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM | Via Medical Corp. | 1996-12-05 |
| K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | S & W Medico Teknik | 1992-05-05 |
| K910453 | TOPS NEEDLE TIP PROBE & PVC TIP PROBE | Baxter Healthcare Corp | 1991-08-13 |
| K905397 | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM | Puritan Bennett Corp. | 1991-05-14 |
| K896311 | OPTEX BLOOD GAS MONITORING SYSTEM | Optex Biomedical | 1990-01-03 |
| K890624 | TISSUE OXYGEN MONITOR SYSTEM, MODEL II | Baxter Healthcare Corp | 1989-12-22 |
| K895150 | CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING | Shiley, Inc. | 1989-11-28 |
| K895149 | NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY | Shiley, Inc. | 1989-11-28 |
| K884063 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM | C.R. Bard, Inc. | 1988-12-16 |
| K875225 | UMBILICAL ARTERY OXYGEN SENSOR | Ohmeda Medical | 1988-03-04 |
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | American Bentley | 1988-02-12 |
| K872125 | BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM | C.R. Bard, Inc. | 1987-12-11 |
| K860808 | CONTINUCATH | Orange Medical Instruments, Inc. | 1986-03-13 |
| K853786 | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 | American Bentley | 1985-10-16 |
| K843912 | INTRAVASCULAR BLOOD GAS SYSTEM | Cardiovascular Devices, Inc. | 1985-01-10 |
Legacy Summary#
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FDA Review#
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