The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Minimed Insulin Pump, Model 505.
| Device ID | K963948 |
| 510k Number | K963948 |
| Device Name: | MINIMED INSULIN PUMP, MODEL 505 |
| Classification | Pump, Infusion, Insulin |
| Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Don Selvey |
| Correspondent | Don Selvey MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1997-04-08 |
| Summary: | summary |