The RHEA Vital Sign Vigilance System— 510(k) K190775

Name: FDA 510(k) clearance K190775
Creator: U.S. Food and Drug Administration
Published: 2019-12-19

Substantially Equivalent

Shenzhen Fiber Medical Technology Co. , Ltd.

FDA 510(k) clearance K190775 for The RHEA Vital Sign Vigilance System, Substantially Equivalent on 2019-12-19. Applicant: Shenzhen Fiber Medical Technology Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Fiber Medical Technology Co. , Ltd.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2019-03-26
Decision date: 2019-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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