510(k) K223681
K223681 is an FDA 510(k) premarket notification submitted by Respiree Pte, Ltd. for the device "Respiree Cardio-Respiratory Monitor". The FDA issued a decision of Substantially Equivalent on March 8, 2023. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Respiree Pte, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2023
- Date Received
- December 8, 2022
- 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