TISSUE OXYGEN MONITOR SYSTEM, MODEL II
FDA 510(k) clearance K890624 · decided 1989-12-22
Clearance details
- K-number
- K890624
- Device name
- TISSUE OXYGEN MONITOR SYSTEM, MODEL II
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1989-02-07
- Decision date
- 1989-12-22
- Days to decision
- 318 days
- Clearance type
- Traditional
- Product code
- CCE
- Device class
- 2
- Regulation number
- 868.1200
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (K935778) | Via Medical Corp. | 1996-12-05 |
| SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA (K912145) | S & W Medico Teknik | 1992-05-05 |
| TOPS NEEDLE TIP PROBE & PVC TIP PROBE (K910453) | Baxter Healthcare Corp | 1991-08-13 |
| PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM (K905397) | Puritan Bennett Corp. | 1991-05-14 |
| OPTEX BLOOD GAS MONITORING SYSTEM (K896311) | Optex Biomedical | 1990-01-03 |
| NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (K895149) | Shiley, Inc. | 1989-11-28 |
| CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (K895150) | Shiley, Inc. | 1989-11-28 |
| BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (K884063) | C.R. Bard, Inc. | 1988-12-16 |
| UMBILICAL ARTERY OXYGEN SENSOR (K875225) | Ohmeda Medical | 1988-03-04 |
| UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (K872896) | American Bentley | 1988-02-12 |
| BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM (K872125) | C.R. Bard, Inc. | 1987-12-11 |
| CONTINUCATH (K860808) | Orange Medical Instruments, Inc. | 1986-03-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |