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 Bt08 Diagnostic Ultrasound System.
| Device ID | K073408 |
| 510k Number | K073408 |
| Device Name: | GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, 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 | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-04 |
| Decision Date | 2007-12-19 |
| Summary: | summary |