Go Dose System— 510(k) K160949
Substantially EquivalentEli Lilly and Company
FDA 510(k) clearance K160949 for Go Dose System, Substantially Equivalent on 2016-12-22. Applicant: Eli Lilly and Company. Device class: 2.
Clearance details
- Applicant
- Eli Lilly and Company
- Product code
- Code NDC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code NDC
view allMore clearances from Eli Lilly and Company
view allAdverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.