The following data is part of a premarket notification filed by Shenzhen Fiber Medical Technology Co. Ltd. with the FDA for The Rhea Vital Sign Vigilance System.
| Device ID | K190775 |
| 510k Number | K190775 |
| Device Name: | The RHEA Vital Sign Vigilance System |
| Classification | Monitor, Breathing Frequency |
| Applicant | Shenzhen Fiber Medical Technology Co. Ltd. Room 501, Sun Mate Science And Technology Mansion 2009 Shahe West Road Shenzhen, CN 518057 |
| Contact | Luo Li |
| Correspondent | Donna-bea Tillman Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-26 |
| Decision Date | 2019-12-19 |