DIASCOPE 2— 510(k) K833689

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K833689 for DIASCOPE 2, Substantially Equivalent on 1984-10-26. Applicant: S & W Medico Teknik.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1983-10-18
Decision date: 1984-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.