K160949 is an FDA 510(k) clearance for the Go Dose System. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on December 22, 2016, 261 days after receiving the submission on April 5, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K160949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2016 |
| Decision Date | December 22, 2016 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NDC — Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |