Last synced on 24 May 2024 at 11:04 pm

Ambu® aScope™ Gastro Large; Ambu® aBox™ 2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232919
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
4/5/2024
Days to Decision
199 days
Submission Type
Summary

Ambu® aScope™ Gastro Large; Ambu® aBox™ 2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232919
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
4/5/2024
Days to Decision
199 days
Submission Type
Summary