PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM— 510(k) K955762
Substantially EquivalentFresenius USA, Inc.
FDA 510(k) clearance K955762 for PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM, Substantially Equivalent on 1996-07-31. Applicant: Fresenius USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Fresenius USA, Inc.
- Product code
- Code KPF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
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