Go Dose System— 510(k) K160949

Substantially Equivalent

Eli Lilly and Company

FDA 510(k) clearance K160949 for Go Dose System, Substantially Equivalent on 2016-12-22. Applicant: Eli Lilly and Company.

Clearance details

Applicant
Eli Lilly and Company
Product code
Code NDC
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
Download summary PDFView on FDA.gov ↗

Adverse 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.