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Renal dialysis / Pharmaceutical industry / Food and Drug Administration / Hemodialysis / Dialysis / Medical device / Hemofiltration / Validation / Center for Devices and Radiological Health / Medicine / Membrane technology / Nephrology


Guidance for Industry and CDRH Reviewers Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems Document issued on: August 7, 1998
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City

Rockville / /

Company

D. SOFTWARE / Hemodialysis Delivery Systems / Materials/Biocompatibility 10 D. Software / /

Country

United States / /

Currency

FKP / /

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IndustryTerm

disinfection protocol / accessory device / software-controlled medical devices / on-line hemodiafiltration / dialysis systems / sub-systems / patient access devices / predicate device / Web/CDRH home page / dialysis solution / offthe-shelf software / appropriate chemical analyses / manufacturing site / water treatment systems / valves ultrafiltration controller mechanism air detector systems / internet address / energy used/delivered / marketed device / /

MedicalCondition

chronic dialysis facility / /

MedicalTreatment

hemodialysis / Hemodiafiltration / dialysis / hemofiltration / /

Organization

U.S. Department of Health And Human Services / Division of Small Manufacturers Assistance / Food and Drug Administration / Center for Devices and Radiological Health / office of Device Evaluation / Food and Drug Administration Center for Devices / Radiological Health / FDA / Renal Devices Branch Division of Reproductive / Abdominal / Ear / Nose and Throat / Throat and Radiological Devices office of Device Evaluation Preface Public Comment Comments / /

Person

Carolyn Y. Neuland / Gastroenterology / Elias Mallis / /

/

Position

Governor / ultrafiltration controller / controller / Chief / /

ProvinceOrState

Maryland / /

Technology

disinfection protocol / dialysis system / dialysis / /

URL

http /

SocialTag