AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM— 510(k) K133989

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K133989 for AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2014-11-25. Applicant: Mortara Instrument, Inc..

Clearance details

Applicant: Mortara Instrument, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2013-12-26
Decision date: 2014-11-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Milwaukee, WI, 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.