NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1— 510(k) K011310

Substantially Equivalent

Nien Made Electrnics Corp.

FDA 510(k) clearance K011310 for NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1, Substantially Equivalent on 2001-07-20. Applicant: Nien Made Electrnics Corp..

Clearance details

Applicant: Nien Made Electrnics Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-04-30
Decision date: 2001-07-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Concord, MA, 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.