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FDA 510(k)

Finger Type Pulse Oximeter

K-Number: K151024 · 2016-03-02

ApplicantTaidoc Technology Corporation
Decision Date2016-03-02
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Finger Type Pulse Oximeter is a medical device manufactured by Taidoc Technology Corporation. It received FDA 510(k) clearance on 2016-03-02 under approval number K151024. 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 Finger Type Pulse Oximeter?

Finger Type Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Taidoc Technology Corporation. The 510(k) number is K151024.

When was Finger Type Pulse Oximeter approved by the FDA?

Finger Type Pulse Oximeter received FDA 510(k) clearance on 2016-03-02, under approval number K151024.

What company makes Finger Type Pulse Oximeter?

Finger Type Pulse Oximeter is manufactured by Taidoc Technology Corporation.

What is the FDA product code for Finger Type Pulse Oximeter?

The FDA product code for Finger Type Pulse Oximeter is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING NCT05914324 Outpatient Pediatric Pulse Oximeters in Africa ACTIVE_NOT_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED NCT07527000 SpO2 Validation Study - All.Health Algo Oximeter Software COMPLETED

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Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

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

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