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FREEDOM Integrated Syringe Infusion System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200176
510(k) Type
Traditional
Applicant
Repro-Med Systems, Inc., dba KORU Medical Systems
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/15/2021
Days to Decision
691 days
Submission Type
Summary

FREEDOM Integrated Syringe Infusion System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200176
510(k) Type
Traditional
Applicant
Repro-Med Systems, Inc., dba KORU Medical Systems
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/15/2021
Days to Decision
691 days
Submission Type
Summary