Decision Date2020-11-27
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Spo2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2020-11-27 under 510(k) 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. The listed applicant is Jkh USA, LLC. The 510(k) number is K202851.
When did Spo2 Sensor receive FDA 510(k) clearance?
Spo2 Sensor received FDA 510(k) clearance on 2020-11-27, under 510(k) number K202851.
Who is the listed applicant for Spo2 Sensor?
The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Spo2 Sensor?
The FDA product code for Spo2 Sensor is DQA.
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Related Devices (Code: DQA)
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K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply 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.