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FDA 510(k)

Handheld VitalSigns Monitoring System

K-Number: K172965 · 2018-12-17

ApplicantVisiomed Technology Co.,Ltd
Decision Date2018-12-17
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Handheld VitalSigns Monitoring System is a medical device manufactured by Visiomed Technology Co.,Ltd. It received FDA 510(k) clearance on 2018-12-17 under approval number K172965. 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 Handheld VitalSigns Monitoring System?

Handheld VitalSigns Monitoring System is a medical device that received FDA 510(k) clearance on 2018-12-17. It is manufactured by Visiomed Technology Co.,Ltd. The 510(k) number is K172965.

When was Handheld VitalSigns Monitoring System approved by the FDA?

Handheld VitalSigns Monitoring System received FDA 510(k) clearance on 2018-12-17, under approval number K172965.

What company makes Handheld VitalSigns Monitoring System?

Handheld VitalSigns Monitoring System is manufactured by Visiomed Technology Co.,Ltd.

What is the FDA product code for Handheld VitalSigns Monitoring System?

The FDA product code for Handheld VitalSigns Monitoring System is MWI.

Related Clinical Trials

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Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Related Devices (Code: MWI)

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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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