Dolphin Medical Stand-Alone Pulse Oximeter, Model 2100

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K021959 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421

  Class II

  FDA 510(k) K030952 Active Cleared 19 May 2003

• Dolphin Medical 2150 Handheld Pulse Oximeter

  Class II

  FDA 510(k) K030629 Active Cleared 4 Sep 2003

• Dolphin Medical Stand-Alone Pulse Oximeter

  Class II

  FDA 510(k) K024235 Active Cleared 17 Mar 2003

• Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420

  Class II

  FDA 510(k) K040380 Active Cleared 31 Aug 2004

• Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070

  Class II

  FDA 510(k) K012989 Active Cleared 20 Mar 2002

• Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210

  Class II

  FDA 510(k) K032947 Active Cleared 17 Oct 2003

See all devices from Dolphin Medical, Inc. →