510(k) K223367

Ochsner Connected Inhaler Sensor by Ochsner Clinic Foundation — Product Code CAF

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