QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100

QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 is an FDA 510(k)-cleared medical device (K083079) manufactured by Quanta Computer, 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 March 4, 2009. Regulation: 8.