510(k) K122483
K122483 is an FDA 510(k) premarket notification submitted by Asante Solutions, Inc. for the device "PEARL DIABETES MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 2013. 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
- January 3, 2013
- Date Received
- August 14, 2012
- 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