AIW WATER SYSTEM FOR HEMODIALYSIS— 510(k) K001282
Substantially EquivalentAmerican Industrial Water
FDA 510(k) clearance K001282 for AIW WATER SYSTEM FOR HEMODIALYSIS, Substantially Equivalent on 2000-12-15. Applicant: American Industrial Water.
Clearance details
- Applicant
- American Industrial Water
- Product code
- Code FIP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wichita, KS, US
Adverse 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.