The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Echopac.
| Device ID | K120221 |
| 510k Number | K120221 |
| Device Name: | GE ECHOPAC |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 9900 W. INNOVATION DRIVE RP-2138 Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE HEALTHCARE 9900 W. INNOVATION DRIVE RP-2138 Wauwatosa, WI 53226 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-25 |
| Decision Date | 2012-03-30 |
| Summary: | summary |