OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR is an FDA 510(k)-cleared medical device (K012626) manufactured by Osi 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 1, 2001. Regulation: 8.