The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Logiq E9 Bt2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4.
| Device ID | K092271 |
| 510k Number | K092271 |
| Device Name: | GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD. W-450 Waukesha, WI 53188 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville GE HEALTHCARE 3000 N. GRANDVIEW BLVD. W-450 Waukesha, WI 53188 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2009-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682143165 | K092271 | 000 |