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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 a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2019-05-28 under approval 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. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K190468.

When was Nihon Kohden SVM-7200 Series Vital Signs Monitor approved by the FDA?

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

What company makes Nihon Kohden SVM-7200 Series Vital Signs Monitor?

Nihon Kohden SVM-7200 Series Vital Signs Monitor is manufactured by Nihon Kohden Corporation.

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.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Nihon Kohden Corporation

K153707Nihon Kohden Vital Sign Telemeter K152305Nihon Kohden Afib Detection Program QP-039P K171765Nihon Kohden CO2 Monitor K171124Nihon Kohden Wireless Input Unit WEE-1200 K163644Nihon Kohden QP-160AK EEG Trend Program K163459Nihon Kohden Vital Sign Telemeter

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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.

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