HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F— 510(k) K081073
Substantially EquivalentPausch, LLC
FDA 510(k) clearance K081073 for HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F, Substantially Equivalent on 2008-12-05. Applicant: Pausch, LLC. Device class: 2.
Clearance details
- Applicant
- Pausch, LLC
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tenton Falls, NJ, US
Recent devices under product code OWB
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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.