ACCUTORR 7 VITAL SIGNS MONITOR— 510(k) K132038

Substantially Equivalent

Mindray North America

FDA 510(k) clearance K132038 for ACCUTORR 7 VITAL SIGNS MONITOR, Substantially Equivalent on 2014-05-02. Applicant: Mindray North America.

Clearance details

Applicant: Mindray North America
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2013-07-01
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mahwh, NJ, US

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.