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FDA 510(k)

Patient Monitor

K-Number: K192343 · 2019-12-31

ApplicantShenzhen Creative Industry Co., Ltd.
Decision Date2019-12-31
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitor is a medical device manufactured by Shenzhen Creative Industry Co., Ltd.. It received FDA 510(k) clearance on 2019-12-31 under approval number K192343. 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 Patient Monitor?

Patient Monitor is a medical device that received FDA 510(k) clearance on 2019-12-31. It is manufactured by Shenzhen Creative Industry Co., Ltd.. The 510(k) number is K192343.

When was Patient Monitor approved by the FDA?

Patient Monitor received FDA 510(k) clearance on 2019-12-31, under approval number K192343.

What company makes Patient Monitor?

Patient Monitor is manufactured by Shenzhen Creative Industry Co., Ltd..

What is the FDA product code for Patient Monitor?

The FDA product code for Patient Monitor is DQA.

Related Clinical Trials

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Other Devices by Shenzhen Creative Industry Co., Ltd.

K170047All-in-One Health Monitor, PC-303 K172792Handheld Pulse Oximeter, Model SP-20 K201468Pulse Oximeter

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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