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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Creative Industry Co., Ltd.. It received FDA 510(k) clearance on 2019-12-31 under 510(k) 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. The listed applicant is Shenzhen Creative Industry Co., Ltd.. The 510(k) number is K192343.

When did Patient Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Patient Monitor?

The FDA 510(k) record lists Shenzhen Creative Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Monitor?

The FDA product code for Patient Monitor is DQA.

Other records listing Shenzhen Creative Industry 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.

K201468Pulse OximeterK172792Handheld Pulse Oximeter, Model SP-20K170047All-in-One Health Monitor, PC-303

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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