The following data is part of a premarket notification filed by Ge Med. Systems Ultrasound & Prim. Care Diag.,llc with the FDA for Ge Logiq 9 Diagnostic Ultrasound System, Model 2404587.
| Device ID | K040251 |
| 510k Number | K040251 |
| Device Name: | GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC 4855 WEST ELECTRIC AVE. P.O. BOX 414 Milwaukee, WI 53219 |
| Contact | Allen Schuh |
| Correspondent | Allen Schuh GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC 4855 WEST ELECTRIC AVE. P.O. BOX 414 Milwaukee, WI 53219 |
| 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 | 2004-02-03 |
| Decision Date | 2004-02-20 |
| Summary: | summary |