The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Ge Echopac Model Bt10.
| Device ID | K101324 |
| 510k Number | K101324 |
| Device Name: | GE ECHOPAC MODEL BT10 |
| Classification | System, Image Processing, Radiological |
| Applicant | GE VINGMED ULTRASOUND AS 9900 W INNOVATION DR. RP-2138 Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE VINGMED ULTRASOUND AS 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 | 2010-05-11 |
| Decision Date | 2010-10-05 |
| Summary: | summary |