510(k) K050312
K050312 is an FDA 510(k) premarket notification submitted by Nipro Diabetes Systems, Inc. for the device "AMIGO INSULIN PUMP". The FDA issued a decision of Substantially Equivalent on May 9, 2005. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Nipro Diabetes Systems, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2005
- Date Received
- Feb 8, 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
- 510(k)