DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION— 510(k) K901477
Substantially EquivalentDelmed, Inc.
FDA 510(k) clearance K901477 for DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION, Substantially Equivalent on 1990-07-27. Applicant: Delmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Delmed, Inc.
- Product code
- Code FKX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
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More clearances from Delmed, Inc.
view allAdverse events under product code FKX
product code FKX- Death
- 501
- Injury
- 6,720
- Malfunction
- 18,508
- Other
- 1
- Total
- 25,730
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.