The following data is part of a premarket notification filed by Infusion Dynamics, Inc. with the FDA for Infusion Dynamics Power Infuser.
| Device ID | K974074 |
| 510k Number | K974074 |
| Device Name: | INFUSION DYNAMICS POWER INFUSER |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | INFUSION DYNAMICS, INC. 116 VILLAGE BOULEVARD, SUITE 200 Princeton, NJ 08540 -5799 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze INFUSION DYNAMICS, INC. 116 VILLAGE BOULEVARD, SUITE 200 Princeton, NJ 08540 -5799 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-29 |
| Decision Date | 1998-02-17 |