The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Ge Echopac.
| Device ID | K150085 |
| 510k Number | K150085 |
| Device Name: | GE EchoPAC |
| Classification | System, Image Processing, Radiological |
| Applicant | GE VINGMED ULTRASOUND AS STRANDPROMENADEN 45 PO BOX 141 Horten, NO 3191 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC 9900 W INNOVATION DR., RP-2138 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 | 2015-01-15 |
| Decision Date | 2015-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104333 | K150085 | 000 |
| 00840682103961 | K150085 | 000 |