EveryWare— 510(k) K242485
Substantially EquivalentBreas Medical AB
FDA 510(k) clearance K242485 for EveryWare, Substantially Equivalent on 2025-05-20. Applicant: Breas Medical AB. Device class: 2.
Clearance details
- Applicant
- Breas Medical AB
- Product code
- Code MOD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Molnlycke, SE
Recent devices under product code MOD
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