Last synced on 25 November 2022 at 11:04 pm

Ambu® aScope™ Gastro, Ambu® aBox™2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212382
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
2/3/2022
Days to Decision
185 days
Submission Type
Summary

Ambu® aScope™ Gastro, Ambu® aBox™2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212382
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
2/3/2022
Days to Decision
185 days
Submission Type
Summary