SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE— 510(k) K141113

Substantially Equivalent

Spacelabs Healthcare, Ltd.

FDA 510(k) clearance K141113 for SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE, Substantially Equivalent on 2014-09-26. Applicant: Spacelabs Healthcare, Ltd..

Clearance details

Applicant: Spacelabs Healthcare, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2014-04-30
Decision date: 2014-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Nederland, CO, US

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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.