The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging System.
| Device ID | K000695 |
| 510k Number | K000695 |
| Device Name: | GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Allen Schuh |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-03-01 |
| Decision Date | 2000-03-16 |