Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is an FDA 510(k)-cleared medical device (K201699) manufactured by Surgical Instrument and Savings Inc (Dba Medline Renewal). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2020. Regulation: 8.