Roche Medical Electronics, Inc.
Mchenry, IL, US
Roche Medical Electronics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Roche Medical Electronics, Inc. between 1976 and 1979. The busiest year on record is 1979, with 10. The most recent is 1979, with 10.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 2 |
| 1979 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K791559 | ROCHE SENSOR ADAPTOR | KLK | Substantially Equivalent | |
| K791039 | FETASONDE FETAL HEART RATE VARIABILITY | HGM | Substantially Equivalent | |
| K791038 | FETASONDE UTERINE ACTIVITY MONITOR | HGM | Substantially Equivalent | |
| K791037 | FETASONDE LABOR STATUS DISPLAY | HGM | Substantially Equivalent | |
| K791036 | FETASONDE UTERINE WORK MONITOR | HGM | Substantially Equivalent | |
| K791035 | FETASONDE FETAL ACTIVITY MONITOR | HGM | Substantially Equivalent | |
| K790761 | FETASONDE MODEL 2108 | HGM | Substantially Equivalent | |
| K790421 | ROCHE LACTATE ANALYZER 640 | KHP | Substantially Equivalent | |
| K782089 | MONITOR, HEART RATE MODEL 103 | DRT | Substantially Equivalent | |
| K782088 | MONITOR, HEART RATE MODEL 105 | DRT | Substantially Equivalent | |
| K781271 | MONITOR, PO2, INTRAVASCULAR | CCE | Substantially Equivalent | |
| K780179 | LIQUID SCINTILLATION COUNTER | JJJ | Substantially Equivalent | |
| K771816 | ROCHE AXISCAN 5 | HEM | Substantially Equivalent | |
| K771478 | INFUSION PUMP #6202 | FRN | Substantially Equivalent | |
| K761057 | ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) | DXN | Substantially Equivalent | |
| K760919 | MODEL 2106 FETA SONDE FETAL MONITOR | HGM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- JJJCounter (Beta, Gamma) For Clinical Use
- HEMImager, Ultrasonic Obstetric-Gynecologic
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- FRNPump, Infusion
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain