Uroview FD II— 510(k) K180651
Substantially EquivalentPausch Medical GmbH
FDA 510(k) clearance K180651 for Uroview FD II, Substantially Equivalent on 2018-04-12. Applicant: Pausch Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Pausch Medical GmbH
- Product code
- Code JAA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erlangen, DE
Recent devices under product code JAA
view allMore clearances from Pausch Medical GmbH
view allAdverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
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.