N-395 PULSE OXIMETER, MODEL N-395

N-395 PULSE OXIMETER, MODEL N-395 is an FDA 510(k)-cleared medical device (K991823) manufactured by Nellcor Puritan Bennett, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 1999. Regulation: 8.