The following data is part of a premarket notification filed by Telemed with the FDA for Logicscan 64 Logicscan 128.
| Device ID | K113184 |
| 510k Number | K113184 |
| Device Name: | LOGICSCAN 64 LOGICSCAN 128 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TELEMED DARIARUS IR GIRENO STREET 42 Vilnius, LT Lt-02189 |
| Contact | Yury Sokolov |
| Correspondent | Yury Sokolov TELEMED DARIARUS IR GIRENO STREET 42 Vilnius, LT Lt-02189 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-28 |
| Decision Date | 2012-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016734034 | K113184 | 000 |
| 07290016734010 | K113184 | 000 |