SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR— 510(k) K103732

Substantially Equivalent

Spacelabs Healthcare, Ltd.

FDA 510(k) clearance K103732 for SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR, Substantially Equivalent on 2011-02-04. Applicant: Spacelabs Healthcare, Ltd..

Clearance details

Applicant: Spacelabs Healthcare, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2010-12-22
Decision date: 2011-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Nederland, CO, 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.