DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET— 510(k) K895990
Substantially EquivalentNational Medical Care, Medical Products Div., Inc.
FDA 510(k) clearance K895990 for DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET, Substantially Equivalent on 1990-03-22. Applicant: National Medical Care, Medical Products Div., Inc.. Device class: 2.
Clearance details
- Applicant
- National Medical Care, Medical Products Div., Inc.
- Product code
- Code KDJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockleigh, NJ, US
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More clearances from National Medical Care, Medical Products Div., Inc.
view allAdverse events under product code KDJ
product code KDJ- Death
- 298
- Injury
- 9,221
- Malfunction
- 8,438
- Other
- 1
- Total
- 17,958
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.