Reusable SpO2 Sensor
K-Number: K191420 · 2019-10-11
Decision Date2019-10-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Reusable SpO2 Sensor is a medical device manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-10-11 under approval number K191420. 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 Reusable SpO2 Sensor?
Reusable SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K191420.
When was Reusable SpO2 Sensor approved by the FDA?
Reusable SpO2 Sensor received FDA 510(k) clearance on 2019-10-11, under approval number K191420.
What company makes Reusable SpO2 Sensor?
Reusable SpO2 Sensor is manufactured by Shenzhen Changke Connect Electronics Co., Ltd..
What is the FDA product code for Reusable SpO2 Sensor?
The FDA product code for Reusable SpO2 Sensor is DQA.
Related Clinical Trials
Other Devices by Shenzhen Changke Connect Electronics Co., Ltd.
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.