The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Aloka 650cl Diagnostic Ultrasound System.
| Device ID | K920374 |
| 510k Number | K920374 |
| Device Name: | ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Brian R Barry |
| Correspondent | Brian R Barry GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-29 |
| Decision Date | 1992-04-02 |