Last synced on 30 September 2022 at 11:05 pm

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173727
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
3/28/2018
Days to Decision
113 days
Submission Type
Summary

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173727
510(k) Type
Traditional
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
3/28/2018
Days to Decision
113 days
Submission Type
Summary