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)

Disposable SpO2 Sensor

K-Number: K200069 · 2020-03-13

ApplicantShenzhen Changke Connect Electronics Co., Ltd.
Decision Date2020-03-13
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable SpO2 Sensor is a medical device manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-13 under approval number K200069. 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 Disposable SpO2 Sensor?

Disposable SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2020-03-13. It is manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K200069.

When was Disposable SpO2 Sensor approved by the FDA?

Disposable SpO2 Sensor received FDA 510(k) clearance on 2020-03-13, under approval number K200069.

What company makes Disposable SpO2 Sensor?

Disposable SpO2 Sensor is manufactured by Shenzhen Changke Connect Electronics Co., Ltd..

What is the FDA product code for Disposable SpO2 Sensor?

The FDA product code for Disposable SpO2 Sensor is DQA.

Related Clinical Trials

NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING NCT07349797 MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure NOT_YET_RECRUITING NCT07335614 Evaluation of Protein Loading on Measurement of Renal Reserve NOT_YET_RECRUITING

Other Devices by Shenzhen Changke Connect Electronics Co., Ltd.

K191428ECG Cable K191420Reusable SpO2 Sensor K191253Reusable NIBP Cuff K193625Disposable Temperature Probe K200026Disposable ECG Cable K193629Disposable NIBP Cuff

View all 8 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.

↑