The following data is part of a premarket notification filed by Infusion Dynamics, Inc. with the FDA for Infusion Dynamics (id) Power Infuser, Model M100b-3a With Blood Cartridge.
| Device ID | K030739 |
| 510k Number | K030739 |
| Device Name: | INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE |
| Classification | Pump, Infusion |
| Applicant | INFUSION DYNAMICS, INC. 5340 SPECTRUM DRIVE, SUITE N Frederick, MD 21703 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze INFUSION DYNAMICS, INC. 5340 SPECTRUM DRIVE, SUITE N Frederick, MD 21703 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-10 |
| Decision Date | 2004-01-14 |