The following data is part of a premarket notification filed by General Electric Co. with the FDA for Logiq 500.
| Device ID | K010329 |
| 510k Number | K010329 |
| Device Name: | LOGIQ 500 |
| Classification | System, Imaging, Pulsed Doppler, 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 | 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 | 2001-02-02 |
| Decision Date | 2001-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682117395 | K010329 | 000 |
| 00840682117388 | K010329 | 000 |
| 00840682117340 | K010329 | 000 |
| 00840682117319 | K010329 | 000 |
| 00840682117302 | K010329 | 000 |