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FEops HEARTguideTM, FEops HEARTguideTM ALPACA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223855
510(k) Type
Traditional
Applicant
FEops nv
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
6/6/2023
Days to Decision
165 days
Submission Type
Summary

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223855
510(k) Type
Traditional
Applicant
FEops nv
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
6/6/2023
Days to Decision
165 days
Submission Type
Summary