The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Logiq 200 Md Diagnostic Ultrasound System.
| Device ID | K992208 |
| 510k Number | K992208 |
| Device Name: | GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Allen Schuh |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-06-30 |
| Decision Date | 1999-07-12 |
| Summary: | summary |