AMADEO M-DR mini, AMADEO M-AX mini— 510(k) K182317
Substantially EquivalentOehm Und Rehbein GmbH
FDA 510(k) clearance K182317 for AMADEO M-DR mini, AMADEO M-AX mini, Substantially Equivalent on 2018-09-24. Applicant: Oehm Und Rehbein GmbH.
Clearance details
- Applicant
- Oehm Und Rehbein GmbH
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rostock, DE
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.