Datalys Multi-Parameter Patient Monitor— 510(k) K150691

Substantially Equivalent

Lutech Industries, Inc.

FDA 510(k) clearance K150691 for Datalys Multi-Parameter Patient Monitor, Substantially Equivalent on 2015-05-15. Applicant: Lutech Industries, Inc..

Clearance details

Applicant: Lutech Industries, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2015-03-18
Decision date: 2015-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, 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.