The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq 500.
| Device ID | K991611 |
| 510k Number | K991611 |
| Device Name: | GE LOGIQ 500 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Allen Schuh |
| Correspondent | Allen Schuh GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-10 |
| Decision Date | 1999-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682117357 | K991611 | 000 |