Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-16 under approval 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. It is manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K221979.

When was Pulse Oximeter (Model C101A2, C101B1, C101A3) approved by the FDA?

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

What company makes Pulse Oximeter (Model C101A2, C101B1, C101A3)?

Pulse Oximeter (Model C101A2, C101B1, C101A3) is manufactured by Shenzhen Imdk Medical Technology Co., Ltd..

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.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED 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 NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by Shenzhen Imdk Medical Technology Co., Ltd.

K173123Pulse Oximeter K180419Ultrasonic Doppler (Model YM-2T8) K243118Arm Blood Pressure Monitor (model: BPM-A7VL) K233040EMS/TENS Massager Device 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)

View all 7 devices →

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.

↑