Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K190775 |
Device Name |
The RHEA Vital Sign Vigilance System |
Applicant |
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 |
Correspondent |
Biologics Consulting Group |
1555 King Street, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Donna-Bea Tillman |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/26/2019 |
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
|
|
|