ESCORT— 510(k) K820858

Substantially Equivalent

Amigo Sales, Inc.

FDA 510(k) clearance K820858 for ESCORT, Substantially Equivalent on 1982-04-08. Applicant: Amigo Sales, Inc..

Clearance details

Applicant
Amigo Sales, Inc.
Product code
Code INM
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code INM

product code INM
Death
3
Total
3

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.