SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR— 510(k) K061430
Substantially EquivalentCustom Ultrasonics
FDA 510(k) clearance K061430 for SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR, Substantially Equivalent on 2007-01-12. Applicant: Custom Ultrasonics. Device class: 2.
Clearance details
- Applicant
- Custom Ultrasonics
- Product code
- Code FEB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ivyland, PA, US
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More clearances from Custom Ultrasonics
view allAdverse events under product code FEB
product code FEB- Malfunction
- 3,879
- Total
- 3,879
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.