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FDA 510(k)

Pulse Oximeter

K-Number: K173123 · 2018-08-13

ApplicantShenzhen Imdk Medical Technology Co., Ltd.
Decision Date2018-08-13
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K173123. 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 Pulse Oximeter?

Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K173123.

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

Pulse Oximeter received FDA 510(k) clearance on 2018-08-13, under 510(k) number K173123.

Who is the listed applicant for Pulse Oximeter?

The FDA 510(k) record lists Shenzhen Imdk Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulse Oximeter?

The FDA product code for 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.

NCT02962557Detecting Post-surgical Respiratory Compromise and Prompting Patients to Self-rescue: An Early Feasibility StudyACTIVE_NOT_RECRUITINGNCT03628560Alternate Methodology of Pulse Oximeter ValidationTERMINATEDNCT04121923Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep ApneaCOMPLETEDNCT04796285A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk MonitorACTIVE_NOT_RECRUITINGNCT04885062Belun Ring Platform With an Improved Algorithm for OSA AssessmentCOMPLETEDNCT05690633Feasibility of Obtaining Pulse Oximetry Readings From the OropharynxCOMPLETED

Other records listing Shenzhen Imdk Medical Technology Co., Ltd. as applicant

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.

K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)K253133Wrist Blood Pressure Monitor (BPM-W1VL)K243118Arm Blood Pressure Monitor (model: BPM-A7VL)K233040EMS/TENS Massager DeviceK221979Pulse Oximeter (Model C101A2, C101B1, C101A3)K180419Ultrasonic Doppler (Model YM-2T8)

View all 7 devices →

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

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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