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FDA 510(k)

The RHEA Vital Sign Vigilance System

K-Number: K190775 · 2019-12-19

ApplicantShenzhen Fiber Medical Technology Co. , Ltd.
Decision Date2019-12-19
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

The RHEA Vital Sign Vigilance System is a medical device manufactured by Shenzhen Fiber Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2019-12-19 under approval number K190775. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The RHEA Vital Sign Vigilance System?

The RHEA Vital Sign Vigilance System is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Shenzhen Fiber Medical Technology Co. , Ltd.. The 510(k) number is K190775.

When was The RHEA Vital Sign Vigilance System approved by the FDA?

The RHEA Vital Sign Vigilance System received FDA 510(k) clearance on 2019-12-19, under approval number K190775.

What company makes The RHEA Vital Sign Vigilance System?

The RHEA Vital Sign Vigilance System is manufactured by Shenzhen Fiber Medical Technology Co. , Ltd..

What is the FDA product code for The RHEA Vital Sign Vigilance System?

The FDA product code for The RHEA Vital Sign Vigilance System is BZQ.

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Related PubMed Literature

PMID: 31997227 A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions. Therapeutic innovation & regulatory science (2020) PMID: 25255810 Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. American journal of epidemiology (2014)

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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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