General Electric Medical Systems Information Techn
Sugarland, TX, US
General Electric Medical Systems Information Techn appears in FDA device records in Sugarland, TX. FDA records list 33 510(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
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for General Electric Medical Systems Information Techn between 1999 and 2002. The busiest year on record is 2002, with 11. The most recent is 2002, with 11.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 9 |
| 2000 | 10 |
| 2001 | 3 |
| 2002 | 11 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023380 | T-WAVE ALTERMANS (TWA) ALGORITHM OPTION | DQK | Substantially Equivalent | |
| K021470 | SEER LIGHT COMPACT DIGITAL HOLTER RECORDER | MWJ | Substantially Equivalent | |
| K023100 | ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS | LLZ | Substantially Equivalent | |
| K021454 | UNITY NETWORK ID | MWI | Substantially Equivalent | |
| K020290 | DASH 3000/4000 PATIENT MONITOR | MHX | Substantially Equivalent | |
| K021366 | MAC-LAB/CARDIOLAB EP/COMBOLAB | DQK | Substantially Equivalent | |
| K020661 | UNITY IS PATIENT VIEWER | MSX | Substantially Equivalent | |
| K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM | MHX | Substantially Equivalent | |
| K020524 | PATIENTNET MONITORING SYSTEM | MSX | Substantially Equivalent | |
| K012467 | SOLAR 8000M SYSTEM | DSI | Substantially Equivalent | |
| K014108 | MAC 5000 ECG ANALYSIS SYSTEM | DQK | Substantially Equivalent | |
| K012466 | BIS/EEG MODULE | OLW | Substantially Equivalent | |
| K011000 | TRAM 2001 MODULE | MHX | Substantially Equivalent | |
| K010164 | ICG MODULE | DSB | Substantially Equivalent | |
| K002957 | SOLAR SPO2 MODULE WITH MASIMO SET | DQA | Substantially Equivalent | |
| K002209 | GE MARQUETTE ECG ANALYSIS PROGRAM | MHX | Substantially Equivalent | |
| K001359 | DASH 3000/4000 PATIENT MONITOR | DSI | Substantially Equivalent | |
| K001268 | GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS | MHX | Substantially Equivalent | |
| K001305 | MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM | DQK | Substantially Equivalent | |
| K001112 | GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC | DXJ | Substantially Equivalent | |
| K000645 | GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 | DPS | Substantially Equivalent | |
| K000779 | APEXPRO TELEMETRY SYSTEM | DSI | Substantially Equivalent | |
| K994430 | IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM | MSX | Substantially Equivalent | |
| K993757 | SOLAR 7/8000 | DSI | Substantially Equivalent | |
| K992948 | MAC-LAB SYSTEM | DQK | Substantially Equivalent | |
| K992929 | DASH 3000 PATIENT MONITOR | MHX | Substantially Equivalent | |
| K991786 | MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION | DPS | Substantially Equivalent | |
| K992637 | MUSE CARDIOVASCULAR INFORMATION SYSTEM | DSI | Substantially Equivalent | |
| K991014 | CASE 8000 EXERCISE TESTING SYSTEM | LOS | Substantially Equivalent | |
| K991905 | COROMETRICS MODEL 171 AND 172 FETAL MONITOR | HGM | Substantially Equivalent | |
| K991739 | COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR | HGM | Substantially Equivalent | |
| K991735 | MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS | LOS | Substantially Equivalent | |
| K990068 | SOLAR 9500 INFORMATION MONITOR | MHX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DQKComputer, Diagnostic, Programmable
- DSIDetector And Alarm, Arrhythmia
- DXJDisplay, Cathode-Ray Tube, Medical
- DPSElectrocardiograph
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- OLWIndex-Generating Electroencephalograph Software
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DSBPlethysmograph, Impedance
- LLZSystem, Image Processing, Radiological
- HGMSystem, Monitoring, Perinatal
- MSXSystem, Network And Communication, Physiological Monitors
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain