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SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193670
510(k) Type
Traditional
Applicant
Quanta Dialysis Technologies Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/23/2020
Days to Decision
358 days
Submission Type
Summary

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193670
510(k) Type
Traditional
Applicant
Quanta Dialysis Technologies Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/23/2020
Days to Decision
358 days
Submission Type
Summary