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FDA 510(k)

Caremed Reusable & Disposable SPO2 Sensors

K-Number: K153184 · 2017-01-04

ApplicantShenzhen Caremed Medical Technology Co., Ltd.
Decision Date2017-01-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Caremed Reusable & Disposable SPO2 Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K153184. 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 Caremed Reusable & Disposable SPO2 Sensors?

Caremed Reusable & Disposable SPO2 Sensors is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K153184.

When did Caremed Reusable & Disposable SPO2 Sensors receive FDA 510(k) clearance?

Caremed Reusable & Disposable SPO2 Sensors received FDA 510(k) clearance on 2017-01-04, under 510(k) number K153184.

Who is the listed applicant for Caremed Reusable & Disposable SPO2 Sensors?

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

What is the FDA product code for Caremed Reusable & Disposable SPO2 Sensors?

The FDA product code for Caremed Reusable & Disposable SPO2 Sensors is DQA.

Other records listing Shenzhen Caremed 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.

K191279Disposable SpO2 SensorK182751Reusable Temperature ProbeK182755Disposable Temperature ProbeK182433Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffK153188Caremed patient cable and leadwires

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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