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Ambu® aScope™ Colon; Ambu® aBox™ 2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230332
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
9/15/2023
Days to Decision
220 days
Submission Type
Summary

Ambu® aScope™ Colon; Ambu® aBox™ 2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230332
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
9/15/2023
Days to Decision
220 days
Submission Type
Summary