The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Minimed Com-station, Hardware-7301; Software-7311.
Device ID | K993012 |
510k Number | K993012 |
Device Name: | MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 |
Classification | Pump, Infusion, Insulin |
Applicant | MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | Jennifer Lyons |
Correspondent | Jennifer Lyons 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 | 1999-09-08 |
Decision Date | 1999-11-15 |
Summary: | summary |