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aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210883
510(k) Type
Special
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
6/17/2021
Days to Decision
84 days
Submission Type
Summary

aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210883
510(k) Type
Special
Applicant
Ambu A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
6/17/2021
Days to Decision
84 days
Submission Type
Summary