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FDA 510(k)

oCare Wrist Pulse Oximeter

K-Number: K183556 · 2019-02-15

ApplicantTaiwan Biophotonic Corporation
Decision Date2019-02-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

oCare Wrist Pulse Oximeter is a medical device manufactured by Taiwan Biophotonic Corporation. It received FDA 510(k) clearance on 2019-02-15 under approval number K183556. 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 oCare Wrist Pulse Oximeter?

oCare Wrist Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2019-02-15. It is manufactured by Taiwan Biophotonic Corporation. The 510(k) number is K183556.

When was oCare Wrist Pulse Oximeter approved by the FDA?

oCare Wrist Pulse Oximeter received FDA 510(k) clearance on 2019-02-15, under approval number K183556.

What company makes oCare Wrist Pulse Oximeter?

oCare Wrist Pulse Oximeter is manufactured by Taiwan Biophotonic Corporation.

What is the FDA product code for oCare Wrist Pulse Oximeter?

The FDA product code for oCare Wrist Pulse Oximeter is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED 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

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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