The following data is part of a premarket notification filed by Elcam Medical Acal with the FDA for Safeport(tm) Manifold (or Stopcock).
| Device ID | K211204 |
| 510k Number | K211204 |
| Device Name: | SafePort(TM) Manifold (or Stopcock) |
| Classification | Stopcock, I.v. Set |
| Applicant | Elcam Medical ACAL Kibbutz Baram Kibbutz Baram, IL 1386000 |
| Contact | Avital Levertov |
| Correspondent | Tali Hazan Elcam Medical ACAL Ramot-Naftali M.P Upper Galilee, IL 1383000 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-22 |
| Decision Date | 2022-09-15 |