FDA 510(k)

PATIENT MONITOR

K-Number: K123711 · 2013-10-01

ApplicantShenzhen Creative Industry Co., Ltd.

Decision Date2013-10-01

Product CodeMWI

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 2013-10-01 under 510(k) number K123711. 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 PATIENT MONITOR?

PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2013-10-01. The listed applicant is Shenzhen Creative Industry Co., Ltd.. The 510(k) number is K123711.

When did PATIENT MONITOR receive FDA 510(k) clearance?

PATIENT MONITOR received FDA 510(k) clearance on 2013-10-01, under 510(k) number K123711.

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 MWI.

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Other records listing Shenzhen Creative Industry Co., Ltd. as applicant

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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.