CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER— 510(k) K942546

Substantially Equivalent

Dynatech/Nevada, Inc.

FDA 510(k) clearance K942546 for CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER, Substantially Equivalent on 1995-01-27. Applicant: Dynatech/Nevada, Inc..

Clearance details

Applicant: Dynatech/Nevada, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1994-05-31
Decision date: 1995-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, 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.