The following data is part of a premarket notification filed by Infusion Dynamics, Inc. with the FDA for Infusion Dynamics Power Infuser Model M100b.
| Device ID | K992044 |
| 510k Number | K992044 |
| Device Name: | INFUSION DYNAMICS POWER INFUSER MODEL M100B |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-17 |
| Decision Date | 1999-09-08 |