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AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130845
510(k) Type
Traditional
Applicant
AMBU A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/2013
Days to Decision
220 days
Submission Type
Summary

AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K130845
510(k) Type
Traditional
Applicant
AMBU A/S
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/2013
Days to Decision
220 days
Submission Type
Summary