The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Dia with the FDA for Ge Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2.
| Device ID | K082185 |
| 510k Number | K082185 |
| Device Name: | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 9900 INNOVATION DR. Wauwatosa, WI 53226 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 9900 INNOVATION DR. Wauwatosa, WI 53226 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-01 |
| Decision Date | 2008-08-15 |
| Summary: | summary |