The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics with the FDA for Logiq E.
| Device ID | K151028 |
| 510k Number | K151028 |
| Device Name: | LOGIQ E |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS 9900 INNOVATION DR. Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS 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 | 2015-04-17 |
| Decision Date | 2015-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146913 | K151028 | 000 |
| 00840682104982 | K151028 | 000 |
| 00840682105392 | K151028 | 000 |
| 00840682106702 | K151028 | 000 |
| 00840682110815 | K151028 | 000 |
| 00840682111157 | K151028 | 000 |
| 00840682112772 | K151028 | 000 |
| 00840682115865 | K151028 | 000 |
| 00840682146081 | K151028 | 000 |
| 00840682146944 | K151028 | 000 |
| 00840682103855 | K151028 | 000 |