ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL— 510(k) K964235

Substantially Equivalent

Industrielle Entwicklung Medizintechnik Und Vertri

FDA 510(k) clearance K964235 for ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL, Substantially Equivalent on 1999-03-02. Applicant: Industrielle Entwicklung Medizintechnik Und Vertri.

Clearance details

Applicant: Industrielle Entwicklung Medizintechnik Und Vertri
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1996-10-23
Decision date: 1999-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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.