510(k) K053177
K053177 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E". The FDA issued a decision of Substantially Equivalent on January 31, 2006. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Medtronic Minimed has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2006
- Date Received
- November 14, 2005
- 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