Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Fingertip Pulse Oximeter MD300CG11/MD300CG51

K-Number: K160268 · 2016-10-14

ApplicantBeijing Choice Electronic Technology Co., Ltd.
Decision Date2016-10-14
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fingertip Pulse Oximeter MD300CG11/MD300CG51 is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K160268. 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 Fingertip Pulse Oximeter MD300CG11/MD300CG51?

Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K160268.

When did Fingertip Pulse Oximeter MD300CG11/MD300CG51 receive FDA 510(k) clearance?

Fingertip Pulse Oximeter MD300CG11/MD300CG51 received FDA 510(k) clearance on 2016-10-14, under 510(k) number K160268.

Who is the listed applicant for Fingertip Pulse Oximeter MD300CG11/MD300CG51?

The FDA 510(k) record lists Beijing Choice Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fingertip Pulse Oximeter MD300CG11/MD300CG51?

The FDA product code for Fingertip Pulse Oximeter MD300CG11/MD300CG51 is DQA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07686341PRecision Integrated Saturation MonitorRECRUITING

Other records listing Beijing Choice Electronic Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232975Pulse Oximeter (MD300C228)K230587Wrist Pulse OximeterK230172Pulse OximeterK220101Pulse OximeterK221992Electronic Pulse StimulatorK211400Pulse Oximeter

View all 14 devices →

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

↑