SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)— 510(k) K151305

Substantially Equivalent

Nonin Medical, Inc.

FDA 510(k) clearance K151305 for SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg), Substantially Equivalent on 2015-08-27. Applicant: Nonin Medical, Inc..

Clearance details

Applicant: Nonin Medical, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2015-05-18
Decision date: 2015-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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.