FDA 510(k)

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER

K-Number: K030629 · 2003-09-04

Decision Date2003-09-04

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Dolphin Medical, Inc.. It received FDA 510(k) clearance on 2003-09-04 under 510(k) number K030629. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER?

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2003-09-04. The listed applicant is Dolphin Medical, Inc.. The 510(k) number is K030629.

When did DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER receive FDA 510(k) clearance?

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER received FDA 510(k) clearance on 2003-09-04, under 510(k) number K030629.

Who is the listed applicant for DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER?

The FDA 510(k) record lists Dolphin Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER?

The FDA product code for DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER is DQA.

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Other records listing Dolphin Medical, Inc. as applicant

K060524DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES K040380DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 K033876DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 K032947NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 K031465MODEL 2100 PULSE OXIMETER K030952DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421

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Related Devices (Code: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.