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FDA 510(k)

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

K-Number: K151287 · 2016-01-06

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2016-01-06
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D is a medical device manufactured by Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2016-01-06 under approval number K151287. 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 Oximeters M70, M70A, M70B, M70C, M70D?

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D is a medical device that received FDA 510(k) clearance on 2016-01-06. It is manufactured by Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K151287.

When was Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D approved by the FDA?

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D received FDA 510(k) clearance on 2016-01-06, under approval number K151287.

What company makes Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D?

Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D is manufactured by Guangdong Biolight Meditech Co., Ltd..

What is the FDA product code for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D?

The FDA product code for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D is DQA.

Related Clinical Trials

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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.

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