The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Logiq 5.
| Device ID | K014097 |
| 510k Number | K014097 |
| Device Name: | GE LOGIQ 5 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS P.O. 414 Milwaukee, WI 53201 |
| Contact | Allen Schuh |
| Correspondent | Allen Schuh GE MEDICAL SYSTEMS P.O. 414 Milwaukee, WI 53201 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-12 |
| Decision Date | 2002-01-10 |
| Summary: | summary |