510(k) K223367
K223367 is an FDA 510(k) premarket notification submitted by Ochsner Clinic Foundation for the device "Ochsner Connected Inhaler Sensor". The FDA issued a decision of Substantially Equivalent on August 30, 2023. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2023
- Date Received
- November 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type