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FDA 510(k)

HANDHELD PULSE OXIMETER

K-Number: K111494 · 2012-01-18

ApplicantBeijing Choice Electronic Technololgy Co., Ltd.
Decision Date2012-01-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HANDHELD PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. It received FDA 510(k) clearance on 2012-01-18 under 510(k) number K111494. 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 HANDHELD PULSE OXIMETER?

HANDHELD PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2012-01-18. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. The 510(k) number is K111494.

When did HANDHELD PULSE OXIMETER receive FDA 510(k) clearance?

HANDHELD PULSE OXIMETER received FDA 510(k) clearance on 2012-01-18, under 510(k) number K111494.

Who is the listed applicant for HANDHELD PULSE OXIMETER?

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

What is the FDA product code for HANDHELD PULSE OXIMETER?

The FDA product code for HANDHELD PULSE OXIMETER is DQA.

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Other records listing Beijing Choice Electronic Technololgy 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.

K160508Electronic Pulse StimulatorK131047FINGERTIP PULSE OXIMETERK130947FINGERTIP PULSE OXIMETERK123871FINGERTIP PULSE OXIMETERK122046WRIST PULSE OXIMETERK112622HANDHELD ECG MONITOR

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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.

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