Company ยท US
Roche Medical Electronics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1979. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGM | System, Monitoring, Perinatal | 7 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| FRN | Pump, Infusion | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 1979 | K791559 | ROCHE SENSOR ADAPTOR Roche Medical Electronics, Inc. | KLK |
| Sep 4, 1979 | K791039 | FETASONDE FETAL HEART RATE VARIABILITY Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791038 | FETASONDE UTERINE ACTIVITY MONITOR Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791037 | FETASONDE LABOR STATUS DISPLAY Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791036 | FETASONDE UTERINE WORK MONITOR Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791035 | FETASONDE FETAL ACTIVITY MONITOR Roche Medical Electronics, Inc. | HGM |
| Jun 1, 1979 | K790761 | FETASONDE MODEL 2108 Roche Medical Electronics, Inc. | HGM |
| May 15, 1979 | K790421 | ROCHE LACTATE ANALYZER 640 Roche Medical Electronics, Inc. | KHP |
| Jan 4, 1979 | K782089 | MONITOR, HEART RATE MODEL 103 Roche Medical Electronics, Inc. | DRT |
| Jan 4, 1979 | K782088 | MONITOR, HEART RATE MODEL 105 Roche Medical Electronics, Inc. | DRT |
| Oct 12, 1978 | K781271 | MONITOR, PO2, INTRAVASCULAR Roche Medical Electronics, Inc. | CCE |
| Feb 23, 1978 | K780179 | LIQUID SCINTILLATION COUNTER Roche Medical Electronics, Inc. | JJJ |
| Oct 19, 1977 | K771816 | ROCHE AXISCAN 5 Roche Medical Electronics, Inc. | HEM |
| Aug 22, 1977 | K771478 | INFUSION PUMP #6202 Roche Medical Electronics, Inc. | FRN |
| Dec 9, 1976 | K761057 | ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) Roche Medical Electronics, Inc. | DXN |
| Nov 16, 1976 | K760919 | MODEL 2106 FETA SONDE FETAL MONITOR Roche Medical Electronics, Inc. | HGM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||