The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge System Five.
| Device ID | K001267 |
| 510k Number | K001267 |
| Device Name: | GE SYSTEM FIVE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Allen Schuh |
| Correspondent | Monica Morrison GE MEDICAL SYSTEMS, INC. P.O. BOX 7550 Madison, WI 53707 |
| 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 | 2000-04-20 |
| Decision Date | 2000-05-12 |