VITA-STAT MODEL 900A— 510(k) K792192

Substantially Equivalent

Vita-Stat Medical Services, Inc.

FDA 510(k) clearance K792192 for VITA-STAT MODEL 900A, Substantially Equivalent on 1979-11-13. Applicant: Vita-Stat Medical Services, Inc..

Clearance details

Applicant: Vita-Stat Medical Services, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1979-11-01
Decision date: 1979-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.