The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Disetronic Multifuse Infusion Pump System.
| Device ID | K001629 |
| 510k Number | K001629 |
| Device Name: | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM |
| Classification | Pump, Infusion |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 7690 CAMERON CIRCLE Fort Myers, FL 33912 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter DISETRONIC MEDICAL SYSTEMS AG 7690 CAMERON CIRCLE Fort Myers, FL 33912 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-26 |
| Decision Date | 2000-06-21 |