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FDA 510(k)

Pulse Oximeter (Model C101A2, C101B1, C101A3)

K-Number: K221979 · 2022-10-16

ApplicantShenzhen Imdk Medical Technology Co., Ltd.
Decision Date2022-10-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse Oximeter (Model C101A2, C101B1, C101A3) 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 2022-10-16 under 510(k) number K221979. 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 (Model C101A2, C101B1, C101A3)?

Pulse Oximeter (Model C101A2, C101B1, C101A3) is a medical device that received FDA 510(k) clearance on 2022-10-16. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K221979.

When did Pulse Oximeter (Model C101A2, C101B1, C101A3) receive FDA 510(k) clearance?

Pulse Oximeter (Model C101A2, C101B1, C101A3) received FDA 510(k) clearance on 2022-10-16, under 510(k) number K221979.

Who is the listed applicant for Pulse Oximeter (Model C101A2, C101B1, C101A3)?

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 (Model C101A2, C101B1, C101A3)?

The FDA product code for Pulse Oximeter (Model C101A2, C101B1, C101A3) is DQA.

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 DeviceK173123Pulse OximeterK180419Ultrasonic Doppler (Model YM-2T8)

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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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