HYDROTONE— 510(k) K974321

Substantially Equivalent

North American Technical Services Corp.

FDA 510(k) clearance K974321 for HYDROTONE, Substantially Equivalent on 1998-06-22. Applicant: North American Technical Services Corp..

Clearance details

Applicant
North American Technical Services Corp.
Product code
Code ILJ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sound Beach, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ILJ

product code ILJ
Death
4
Total
4

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.