510(k) K220111
K220111 is an FDA 510(k) premarket notification submitted by Pmd Solutions for the device "RespiraSense". The FDA issued a decision of Substantially Equivalent on October 7, 2022. 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
- October 7, 2022
- Date Received
- January 13, 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