H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS— 510(k) K993520
Substantially EquivalentServ-A-Pure Co.
FDA 510(k) clearance K993520 for H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS, Substantially Equivalent on 2000-05-03. Applicant: Serv-A-Pure Co.. Device class: 2.
Clearance details
- Applicant
- Serv-A-Pure Co.
- Product code
- Code FIP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bay City, MI, US
Recent devices under product code FIP
view allAdverse events under product code FIP
product code FIP- Malfunction
- 490
- Total
- 490
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.