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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Fiber Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) 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. The listed applicant is Shenzhen Fiber Medical Technology Co. , Ltd.. The 510(k) number is K190775.

When did The RHEA Vital Sign Vigilance System receive FDA 510(k) clearance?

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

Who is the listed applicant for The RHEA Vital Sign Vigilance System?

The FDA 510(k) record lists Shenzhen Fiber Medical Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: BZQ)

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.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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