DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM— 510(k) K013358

Substantially Equivalent

Pulse Metric, Inc.

FDA 510(k) clearance K013358 for DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2001-12-13. Applicant: Pulse Metric, Inc..

Clearance details

Applicant: Pulse Metric, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-10-10
Decision date: 2001-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.