510(k) K190775
K190775 is an FDA 510(k) premarket notification submitted by Shenzhen Fiber Medical Technology Co. , Ltd. for the device "The RHEA Vital Sign Vigilance System". The FDA issued a decision of Substantially Equivalent on December 19, 2019. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2019
- Date Received
- March 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type