510(k) K223729
K223729 is an FDA 510(k) premarket notification submitted by Medella Health Limited for the device "FLOWpresso". The FDA issued a decision of Substantially Equivalent on December 21, 2023. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2023
- Date Received
- December 13, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type