DeviceClearance

ACOH WELLNESS TESTER— 510(k) K823554

Substantially Equivalent

Occupational Health, Inc.

FDA 510(k) clearance K823554 for ACOH WELLNESS TESTER, Substantially Equivalent on 1983-01-05. Applicant: Occupational Health, Inc.. Device class: 2.

Clearance details

Applicant
Occupational Health, Inc.
Product code
Code EWO
Device class
Class 2
Regulation
21 CFR 874.1050
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code EWO

view all

Adverse events under product code EWO

product code EWO
Other
2
Total
2

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.