510(k) K203155
K203155 is an FDA 510(k) premarket notification submitted by Breathesuite, Inc. for the device "BreatheSuite MDI V1". The FDA issued a decision of Substantially Equivalent on Sep 17, 2021. 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
- Sep 17, 2021
- Date Received
- Oct 22, 2020
- 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
- 510(k)