PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)

PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) is an FDA 510(k)-cleared medical device (K132075) manufactured by Mindray North America. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 17, 2014. Regulation: 8.