510(k) K223573
K223573 is an FDA 510(k) premarket notification submitted by Onera B.V. for the device "Onera Sleep Test System (Onera STS)". The FDA issued a decision of Substantially Equivalent on August 18, 2023. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Onera B.V. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2023
- Date Received
- November 30, 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