510(k) K100947
K100947 is an FDA 510(k) premarket notification submitted by Calibra Medical, Inc. for the device "FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000". The FDA issued a decision of Substantially Equivalent on Jun 28, 2010. The device falls under product code OPP (Pump, Infusion, Insulin Bolus), a Class II device regulated under 21 CFR 880.5725. Calibra Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 28, 2010
- Date Received
- Apr 6, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Insulin Bolus
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- CH
- Submission Type
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.