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FDA 510(k)

All-in-One Health Monitor, PC-303

K-Number: K170047 · 2017-09-09

ApplicantShenzhen Creative Industry Co., Ltd.
Decision Date2017-09-09
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

All-in-One Health Monitor, PC-303 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 2017-09-09 under 510(k) number K170047. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the All-in-One Health Monitor, PC-303?

All-in-One Health Monitor, PC-303 is a medical device that received FDA 510(k) clearance on 2017-09-09. The listed applicant is Shenzhen Creative Industry Co., Ltd.. The 510(k) number is K170047.

When did All-in-One Health Monitor, PC-303 receive FDA 510(k) clearance?

All-in-One Health Monitor, PC-303 received FDA 510(k) clearance on 2017-09-09, under 510(k) number K170047.

Who is the listed applicant for All-in-One Health Monitor, PC-303?

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 All-in-One Health Monitor, PC-303?

The FDA product code for All-in-One Health Monitor, PC-303 is MWI.

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 OximeterK192343Patient MonitorK172792Handheld Pulse Oximeter, Model SP-20

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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