The following data is part of a premarket notification filed by Telemed with the FDA for Echo Blaster.
| Device ID | K102253 |
| 510k Number | K102253 |
| Device Name: | ECHO BLASTER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TELEMED DARIARUS IR GIRENO STREET 42 Vilnius, LT Lt-02189 |
| Contact | Yury Sokolov |
| Correspondent | Norbert Stuiber TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2011-03-14 |
| Summary: | summary |