Spo2 Sensor
K-Number: K202851 · 2020-11-27
ApplicantJkh USA, LLC
Decision Date2020-11-27
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Spo2 Sensor is a medical device manufactured by Jkh USA, LLC. It received FDA 510(k) clearance on 2020-11-27 under approval number K202851. 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 Spo2 Sensor?
Spo2 Sensor is a medical device that received FDA 510(k) clearance on 2020-11-27. It is manufactured by Jkh USA, LLC. The 510(k) number is K202851.
When was Spo2 Sensor approved by the FDA?
Spo2 Sensor received FDA 510(k) clearance on 2020-11-27, under approval number K202851.
What company makes Spo2 Sensor?
Spo2 Sensor is manufactured by Jkh USA, LLC.
What is the FDA product code for Spo2 Sensor?
The FDA product code for Spo2 Sensor is DQA.
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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.