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FDA 510(k)

Nihon Kohden SVM-7200 Series Vital Signs Monitor

K-Number: K190468 · 2019-05-28

ApplicantNihon Kohden Corporation
Decision Date2019-05-28
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nihon Kohden SVM-7200 Series Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2019-05-28 under 510(k) number K190468. 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 Nihon Kohden SVM-7200 Series Vital Signs Monitor?

Nihon Kohden SVM-7200 Series Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2019-05-28. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K190468.

When did Nihon Kohden SVM-7200 Series Vital Signs Monitor receive FDA 510(k) clearance?

Nihon Kohden SVM-7200 Series Vital Signs Monitor received FDA 510(k) clearance on 2019-05-28, under 510(k) number K190468.

Who is the listed applicant for Nihon Kohden SVM-7200 Series Vital Signs Monitor?

The FDA 510(k) record lists Nihon Kohden Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nihon Kohden SVM-7200 Series Vital Signs Monitor?

The FDA product code for Nihon Kohden SVM-7200 Series Vital Signs Monitor is MWI.

Related Clinical Trials

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Other records listing Nihon Kohden Corporation as applicant

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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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