510(k) K161865
K161865 is an FDA 510(k) premarket notification submitted by Isag Rx, Inc. for the device "iSage Rx (iSage Rx Basal Insulin Titration)". The FDA issued a decision of Substantially Equivalent on Mar 7, 2017. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 7, 2017
- Date Received
- Jul 7, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type
- 510(k)