VSI 1000— 510(k) K912921

Substantially Equivalent

Vitaltrends Technology, Inc.

FDA 510(k) clearance K912921 for VSI 1000, Substantially Equivalent on 1992-10-30. Applicant: Vitaltrends Technology, Inc..

Clearance details

Applicant: Vitaltrends Technology, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1991-07-03
Decision date: 1992-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.