SQUINN VITATEK 500 SERIES PHYSIOL. MONI— 510(k) K810755

Substantially Equivalent

Vitatek

FDA 510(k) clearance K810755 for SQUINN VITATEK 500 SERIES PHYSIOL. MONI, Substantially Equivalent on 1981-04-03. Applicant: Vitatek.

Clearance details

Applicant: Vitatek
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1981-03-20
Decision date: 1981-04-03
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.