Roche Medical Electronics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 16
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K791559 | ROCHE SENSOR ADAPTOR | November 21, 1979 |
| K791039 | FETASONDE FETAL HEART RATE VARIABILITY | September 4, 1979 |
| K791037 | FETASONDE LABOR STATUS DISPLAY | September 4, 1979 |
| K791035 | FETASONDE FETAL ACTIVITY MONITOR | September 4, 1979 |
| K791036 | FETASONDE UTERINE WORK MONITOR | September 4, 1979 |
| K791038 | FETASONDE UTERINE ACTIVITY MONITOR | September 4, 1979 |
| K790761 | FETASONDE MODEL 2108 | June 1, 1979 |
| K790421 | ROCHE LACTATE ANALYZER 640 | May 15, 1979 |
| K782089 | MONITOR, HEART RATE MODEL 103 | January 4, 1979 |
| K782088 | MONITOR, HEART RATE MODEL 105 | January 4, 1979 |
| K781271 | MONITOR, PO2, INTRAVASCULAR | October 12, 1978 |
| K780179 | LIQUID SCINTILLATION COUNTER | February 23, 1978 |
| K771816 | ROCHE AXISCAN 5 | October 19, 1977 |
| K771478 | INFUSION PUMP #6202 | August 22, 1977 |
| K761057 | ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) | December 9, 1976 |
| K760919 | MODEL 2106 FETA SONDE FETAL MONITOR | November 16, 1976 |