The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Minimed External Infusion Pump For Diagetics 504.
| Device ID | K844851 |
| 510k Number | K844851 |
| Device Name: | MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504 |
| Classification | Pump, Infusion |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Nestor Kusnierz |
| Correspondent | Nestor Kusnierz PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-13 |
| Decision Date | 1985-01-22 |