AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS— 510(k) K051031
Substantially EquivalentAmeriwater
FDA 510(k) clearance K051031 for AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS, Substantially Equivalent on 2006-01-06. Applicant: Ameriwater. Device class: 2.
Clearance details
- Applicant
- Ameriwater
- Product code
- Code FIN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dayton, OH, US
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More clearances from Ameriwater
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