CMS-2000— 510(k) K982843

Substantially Equivalent

Industrial Technology Research Institute

FDA 510(k) clearance K982843 for CMS-2000, Substantially Equivalent on 1998-11-10. Applicant: Industrial Technology Research Institute.

Clearance details

Applicant
Industrial Technology Research Institute
Product code
Code MWJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hsinchu,, TW
Download summary PDFView on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

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.