Medical Device Manufacturer · US , Tampa , FL

Osi Medical, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2001

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osi Medical, Inc. Anesthesiology ✕

3 devices

1-3 of 3

Cleared Nov 02, 2001

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE...

Anesthesiology · 81d

Cleared Aug 22, 2001

MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES

Anesthesiology · 16d

Cleared Apr 17, 2001

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL...

Anesthesiology · 286d