510(k) K222950
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2023
- Date Received
- September 27, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type