510(k) K160949
K160949 is an FDA 510(k) premarket notification submitted by Eli Lilly and Company for the device "Go Dose System". The FDA issued a decision of Substantially Equivalent on December 22, 2016. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Eli Lilly and Company has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2016
- Date Received
- April 5, 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