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 Ultrasound Bt03/iq, Model 2375600-x.
| Device ID | K032656 |
| 510k Number | K032656 |
| Device Name: | GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC 4855 WEST ELECTRIC AVE. West Milwaukee, WI 53219 |
| Contact | Allen Schuh |
| Correspondent | Allen Schuh GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC 4855 WEST ELECTRIC AVE. West 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 | 2003-08-28 |
| Decision Date | 2003-10-30 |
| Summary: | summary |