My Dose Coach— 510(k) K171230

Substantially Equivalent

Sanofi

FDA 510(k) clearance K171230 for My Dose Coach, Substantially Equivalent on 2017-05-26. Applicant: Sanofi.

Clearance details

Applicant: Sanofi
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 2017-04-27
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.