The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq 7 Ultrasound Bt05.
| Device ID | K052441 |
| 510k Number | K052441 |
| Device Name: | GE LOGIQ 7 ULTRASOUND BT05 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GENERAL ELECTRIC CO. 4855 WEST ELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53219 |
| Contact | Allen Schuh |
| Correspondent | Allen Schuh GENERAL ELECTRIC CO. 4855 WEST ELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53219 |
| 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 | 2005-09-06 |
| Decision Date | 2005-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682110198 | K052441 | 000 |
| 00840682110181 | K052441 | 000 |
| 00840682109901 | K052441 | 000 |
| 00840682106627 | K052441 | 000 |