The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Logiq 500 Diagnostic Ultrasound System.
| Device ID | K970901 |
| 510k Number | K970901 |
| Device Name: | GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | David Duersteler |
| Correspondent | David Duersteler GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-11 |
| Decision Date | 1997-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682117371 | K970901 | 000 |
| 00840682117265 | K970901 | 000 |