The following data is part of a premarket notification filed by Viltechmeda with the FDA for Sep-10s Plus, And Sp-12s Pro..
| Device ID | K010937 |
| 510k Number | K010937 |
| Device Name: | SEP-10S PLUS, AND SP-12S PRO. |
| Classification | Pump, Infusion |
| Applicant | VILTECHMEDA 125 KALVARIJU ST. LT-2042 Vilnius, LT Lt-2042 |
| Contact | Koby Ben-barak |
| Correspondent | Koby Ben-barak VILTECHMEDA 125 KALVARIJU ST. LT-2042 Vilnius, LT Lt-2042 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-29 |
| Decision Date | 2001-06-25 |