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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 the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Biophotonic Corporation. It received FDA 510(k) clearance on 2019-02-15 under 510(k) 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. The listed applicant is Taiwan Biophotonic Corporation. The 510(k) number is K183556.

When did oCare Wrist Pulse Oximeter receive FDA 510(k) clearance?

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

Who is the listed applicant for oCare Wrist Pulse Oximeter?

The FDA 510(k) record lists Taiwan Biophotonic Corporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05995613Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of ColorCOMPLETED

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse 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 SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® 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.

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