BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
FDA 510(k) clearance K954501 · decided 1996-01-16
Clearance details
- K-number
- K954501
- Device name
- BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
- Applicant
- Medtronic Bio-Medicus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-28
- Decision date
- 1996-01-16
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- DTY
- Device class
- 2
- Regulation number
- 870.4410
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, 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 |
| CDI (TM) SYSTEM 100 MONITORING SYSTEM (K902654) | 3M Health Care, Ltd. | 1990-11-05 |
| 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
No recalls on record reference this clearance.