The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics with the FDA for Echopac Software Only, Echopac Plug-in.
| Device ID | K200852 |
| 510k Number | K200852 |
| Device Name: | EchoPAC Software Only, EchoPAC Plug-In |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Medical Systems Ultrasound And Primary Care Diagnostics 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146876 | K200852 | 000 |
| 00840682146883 | K200852 | 000 |