The following data is part of a premarket notification filed by Bard Access Systems, Inc(bas)[wholly-owned Subsidiary Of Bd] with the FDA for Bd Intraosseous Infusion System.
| Device ID | K203193 |
| 510k Number | K203193 |
| Device Name: | BD Intraosseous Infusion System |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Bard Access Systems, Inc(BAS)[Wholly-owned Subsidiary Of BD] 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Connor Dahl |
| Correspondent | Connor Dahl Bard Access Systems, Inc(BAS)[Wholly-owned Subsidiary Of BD] 605 North 5600 West Salt Lake City, UT 84116 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-28 |
| Decision Date | 2021-03-04 |