510(k) K160673
K160673 is an FDA 510(k) premarket notification submitted by Insulin Algorithms for the device "Insulin Algorithms System". The FDA issued a decision of Substantially Equivalent on Jun 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
- Jun 7, 2017
- Date Received
- Mar 10, 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)