Last synced on 2 December 2022 at 11:04 pm

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210661
510(k) Type
Traditional
Applicant
Quanta Dialysis Technologies Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
8/12/2021
Days to Decision
161 days
Submission Type
Summary

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210661
510(k) Type
Traditional
Applicant
Quanta Dialysis Technologies Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
8/12/2021
Days to Decision
161 days
Submission Type
Summary