OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' is an FDA 510(k)-cleared medical device (K014218) 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 November 6, 2002. Regulation: 8.