The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Ez-io Intraosseous Infusion System.
| Device ID | K132583 |
| 510k Number | K132583 |
| Device Name: | EZ-IO INTRAOSSEOUS INFUSION SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | VIDACARE CORPORATION 4350 LOCKHILL SELMA ROAD Shavano Park, TX 78249 -2095 |
| Contact | Larry J Miller |
| Correspondent | Larry J Miller VIDACARE CORPORATION 4350 LOCKHILL SELMA ROAD Shavano Park, TX 78249 -2095 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-16 |
| Decision Date | 2014-02-11 |
| Summary: | summary |