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OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER - Mod

by Osi Medical, Inc.

510(k) K002036

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002036 Date17 Apr 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Models / Variants
Mod
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100, is a device used for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is used in conjunction with the Digital Dolphin Optical Sensor, a clip-on finger probe. The device provides a noninvasive method for monitoring oxygen saturation and pulse rate. The Digital Dolphin Optical Sensor is designed to be used with the stand-alone pulse oximeter.

The Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100, and Digital Dolphin Optical Sensor are supplied as a system for monitoring SpO2 and pulse rate. The device has received FDA 510(k) clearance, with the K number K002036. The device is a Class 2 medical device, and its use is intended for continuous monitoring of oxygen saturation and pulse rate in a clinical setting.

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