Go Dose System
FDA 510(k) K160949 · Eli Lilly and Company
510(k) numberK160949
Submission
- Device name
- Go Dose System
- Applicant
- Eli Lilly and Company
Indianapolis, IN, US - Received
- April 5, 2016
- Decision date
- December 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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Questions and answers
When was Go Dose System cleared by the FDA?
Go Dose System (K160949) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 261 days after the submission was received.
What is the product code of K160949?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.