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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, breathing frequency
510(k) Number K190775
Device Name The RHEA Vital Sign Vigilance System
Shenzhen Fiber Medical Technology Co. Ltd.
Room 501, Sun Mate Science and Technology Mansion
2009 Shahe West Road
Shenzhen,  CN 518057
Applicant Contact Luo Li
Biologics Consulting Group
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number868.2375
Classification Product Code
Subsequent Product Code
Date Received03/26/2019
Decision Date 12/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03332147
Reviewed by Third Party No
Combination Product No