510(k) K142619
K142619 is an FDA 510(k) premarket notification submitted by Asante Solutions, Inc. for the device "Snap Insulin Pump System". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Asante Solutions, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2014
- Date Received
- September 16, 2014
- Clearance Type
- Special
- 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