The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Diabetes Data Management System (ddms), Model 7333.
Device ID | K032164 |
510k Number | K032164 |
Device Name: | DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 |
Classification | Pump, Infusion, Insulin |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
Contact | Gerda P Resch |
Correspondent | Gerda P Resch MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
Product Code | LZG |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-15 |
Decision Date | 2003-10-23 |
Summary: | summary |