The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics with the FDA for Logiq P10, Logiq P9, Logiq P8.
| Device ID | K203114 |
| 510k Number | K203114 |
| Device Name: | LOGIQ P10, LOGIQ P9, LOGIQ P8 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics ,LLC 9900 Innovation Dr. Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Medical Systems Ultrasound And Primary Care Diagnostics ,LLC 9900 Innovation Dr. Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-15 |
| Decision Date | 2021-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278236005 | K203114 | 000 |
| 00195278111272 | K203114 | 000 |
| 00195278111265 | K203114 | 000 |
| 00195278111258 | K203114 | 000 |
| 00195278111241 | K203114 | 000 |