Clearo— 510(k) K242438
Substantially EquivalentBreas Medical AB
FDA 510(k) clearance K242438 for Clearo, Substantially Equivalent on 2025-05-16. Applicant: Breas Medical AB. Device class: 2.
Clearance details
- Applicant
- Breas Medical AB
- Product code
- Code NHJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Molnlycke, SE
Recent devices under product code NHJ
view allMore clearances from Breas Medical AB
view allAdverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.