SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface— 510(k) K190560

Substantially Equivalent

Nonin Medical, Inc.

FDA 510(k) clearance K190560 for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface, Substantially Equivalent on 2019-05-02. Applicant: Nonin Medical, Inc..

Clearance details

Applicant: Nonin Medical, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2019-03-05
Decision date: 2019-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

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.