The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for 6vt-d Ultrasound Transducer.
| Device ID | K141093 |
| 510k Number | K141093 |
| Device Name: | 6VT-D ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GE VINGMED ULTRASOUND AS STRANDPROMENADEN 45 Horten, NO N-3183 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE VINGMED ULTRASOUND AS STRANDPROMENADEN 45 Horten, NO N-3183 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-28 |
| Decision Date | 2014-05-15 |
| Summary: | summary |