DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 is an FDA 510(k)-cleared medical device (K021959) manufactured by Dolphin Medical, 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 July 10, 2002. Regulation: 8.