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. Device class: 2.
Clearance details
- Applicant
- Oehm Und Rehbein GmbH
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rostock, DE
Recent devices under product code IZL
view allMore clearances from Oehm Und Rehbein GmbH
view allAdverse 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 →
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