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)

Finger Pulse Oximeter, Model: X1906P

K-Number: K221798 · 2023-05-04

ApplicantShenzhen Changkun Technology Co., Ltd.
Decision Date2023-05-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Finger Pulse Oximeter, Model: X1906P is a medical device manufactured by Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-04 under approval number K221798. 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 Finger Pulse Oximeter, Model: X1906P?

Finger Pulse Oximeter, Model: X1906P is a medical device that received FDA 510(k) clearance on 2023-05-04. It is manufactured by Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K221798.

When was Finger Pulse Oximeter, Model: X1906P approved by the FDA?

Finger Pulse Oximeter, Model: X1906P received FDA 510(k) clearance on 2023-05-04, under approval number K221798.

What company makes Finger Pulse Oximeter, Model: X1906P?

Finger Pulse Oximeter, Model: X1906P is manufactured by Shenzhen Changkun Technology Co., Ltd..

What is the FDA product code for Finger Pulse Oximeter, Model: X1906P?

The FDA product code for Finger Pulse Oximeter, Model: X1906P 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 NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING 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

Other Devices by Shenzhen Changkun Technology Co., Ltd.

K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 K193386Wrist Electronic Sphygmomanometer K193387Arm Electronic Sphygmomanometer K231595Electric Breast Pump K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

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.

↑