The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Powered Pd-io Intraosseous Infusion System.
| Device ID | K051992 |
| 510k Number | K051992 |
| Device Name: | POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-22 |
| Decision Date | 2005-10-20 |
| Summary: | summary |