N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS

N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS is an FDA 510(k)-cleared medical device (K993637) 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 November 23, 1999. Regulation: 8.