System 83 Plus Washer/Disinfector— 510(k) K173590
Substantially EquivalentCustom Ultrasonics, Inc.
FDA 510(k) clearance K173590 for System 83 Plus Washer/Disinfector, Substantially Equivalent on 2020-03-30. Applicant: Custom Ultrasonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Custom Ultrasonics, Inc.
- 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, Inc.
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.