OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD is an FDA 510(k)-cleared medical device (K002036) 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 April 16, 2001. Regulation: 8.