CDI (TM) SYSTEM 100 MONITORING SYSTEM
FDA 510(k) clearance K902654 · decided 1990-11-05
Clearance details
- K-number
- K902654
- Device name
- CDI (TM) SYSTEM 100 MONITORING SYSTEM
- Applicant
- 3M Health Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-15
- Decision date
- 1990-11-05
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- DTY
- Device class
- 2
- Regulation number
- 870.4410
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, 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 |
|---|---|---|
| BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM (K093650) | Medtronic, Inc. | 2010-02-17 |
| CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (K963698) | International Biophysics Corp. | 1997-03-20 |
| BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (K954501) | Medtronic Bio-Medicus, Inc. | 1996-01-16 |
| PERFUSION MONITOR (K900860) | Cardio Metrics, Inc. | 1990-08-14 |
| MODIFIED GAS-STAT(TM) MONITORING SYSTEM (K864703) | Cardiovascular Devices, Inc. | 1987-02-19 |
| GAST STAT MONITORING SYSTEM (K840749) | Cardiovascular Devices, Inc. | 1984-04-17 |
| EXTRACORPOREAL BLOOD GAS SYSTEM (K822000) | Cardiovascular Devices, Inc. | 1982-12-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, cat recall (Z-2683-2011) | Terumo Cardiovascular Systems Corporation | 2011-06-28 |
| Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, cat recall (Z-2684-2011) | Terumo Cardiovascular Systems Corporation | 2011-06-28 |
| CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM recall (Z-2610-2011) | Terumo Cardiovascular Systems Corporation | 2011-06-22 |
| Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitorin recall (Z-1943-2011) | Terumo Cardiovascular Systems Corporation | 2011-04-11 |
| Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitori recall (Z-1944-2011) | Terumo Cardiovascular Systems Corporation | 2011-04-11 |