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.. Device class: 1.

Clearance details

Applicant
Amigo Sales, Inc.
Product code
Code INM
Device class
Class 1
Regulation
21 CFR 890.3100
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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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.