MS-2000— 510(k) K961144

Substantially Equivalent

Touritu Engineering Co., Inc.

FDA 510(k) clearance K961144 for MS-2000, Substantially Equivalent on 1997-03-12. Applicant: Touritu Engineering Co., Inc..

Clearance details

Applicant: Touritu Engineering Co., Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1996-03-21
Decision date: 1997-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jaun Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.