Medical Device Manufacturer · US , Littleton , CO

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

12 submissions · 12 cleared · Since 2002

12

Total

12

Cleared

0

Denied

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

12 devices

1-12 of 12

Cleared Jun 15, 2006

DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND...

Anesthesiology · 108d

Cleared Aug 31, 2004

DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420

Anesthesiology · 196d

Cleared Mar 11, 2004

DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323,...

Anesthesiology · 87d

Cleared Oct 17, 2003

NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

Anesthesiology · 25d

Cleared Oct 10, 2003

MODEL 2100 PULSE OXIMETER

Anesthesiology · 155d

Cleared Sep 04, 2003

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER

Anesthesiology · 189d

Cleared May 19, 2003

DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC,...

Anesthesiology · 54d

Cleared Mar 17, 2003

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER

Anesthesiology · 84d

Cleared Nov 07, 2002

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER

Anesthesiology · 321d

Cleared Jul 11, 2002

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100

Anesthesiology · 27d

Cleared Mar 20, 2002

DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070

Anesthesiology · 195d

Cleared Feb 08, 2002

MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER

Anesthesiology · 30d