Dolphin 2313

• FDA 510(k) K030952 decided 19 May 2003 Active
• FDA GUDID UDI-DI 00859998006286 listed 11 Jan 2017 Listed

1. 19 May 2003 Cleared FDA 510(k) K030952
2. 11 Jan 2017 Listed FDA GUDID 00859998006286

Trade name

Dolphin

Generic name

Pulse oximeter probe, single-use

Model / reference

2313

Primary DI / UDI-DI

00859998006286

510(k) Number

K030952 ↗

FDA product code

DQA

GMDN term

Pulse oximeter probe, single-use

Device class

Class II

Regulation number

870.2700

GUDID distribution status

In Commercial Distribution

Category: Pulse oximeter probe, single-use

Other devices filed under Pulse oximeter probe, single-use.

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• Sterile Pulse Oximeter Probe S0005J-LPS by Shenzhen Med-Link Electronics Tech Co., Ltd.
• MasimoSET® M-LNCS™ NeoPt-500 SpO2 Neonatal Pulse Oximeter Adhesive Sensor 2518 by MASIMO CORPORATION
• 8000SS 6837-800 by Nonin Medical, Inc.
• Reusable Soft SpO2 Sensor FMT-RAS(B)/CHC-LR by METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ
• MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor 1895 by MASIMO CORPORATION
• Disposable SpO2 Sensor by Shenzhen SINO-K Medical Technology Co., Ltd

• BluSat 4343

  Class II

  GUDID on market

• Dolphin 2311

  Class II

  FDA 510(k) K030952 Active Cleared 19 May 2003 GUDID on market

• Dolphin 3312-V

  Class II

  FDA 510(k) K030952 Active Cleared 19 May 2003 GUDID on market

• Dolphin 2312

  Class II

  FDA 510(k) K030952 Active Cleared 19 May 2003 GUDID on market

See all devices from OSI Optoelectronics →