ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC— 510(k) K904088

Substantially Equivalent

Sentinel

FDA 510(k) clearance K904088 for ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC, Substantially Equivalent on 1991-02-05. Applicant: Sentinel.

Clearance details

Applicant: Sentinel
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1990-09-05
Decision date: 1991-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.