The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Ge Echopac.
| Device ID | K131685 |
| 510k Number | K131685 |
| Device Name: | GE ECHOPAC |
| Classification | System, Image Processing, Radiological |
| Applicant | GE VINGMED ULTRASOUND AS STRANDPROMENADEN 45 PO BOX 141 Horten, NO N-3191 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE VINGMED ULTRASOUND AS STRANDPROMENADEN 45 PO BOX 141 Horten, NO N-3191 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682121095 | K131685 | 000 |