510(k) K060876
K060876 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA". The FDA issued a decision of Substantially Equivalent on June 15, 2006. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2006
- Date Received
- March 31, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Insulin
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type