FLOWpresso— 510(k) K223729
Substantially EquivalentMedella Health Limited
FDA 510(k) clearance K223729 for FLOWpresso, Substantially Equivalent on 2023-12-21. Applicant: Medella Health Limited. Device class: 2.
Clearance details
- Applicant
- Medella Health Limited
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tauranga, NZ
Recent devices under product code IRP
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