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AERONEB SOLO; AERONEB SOLO ADAPTER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133360
510(k) Type
Traditional
Applicant
AEROGEN LTD
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
10/17/2014
Days to Decision
350 days
Submission Type
Summary

AERONEB SOLO; AERONEB SOLO ADAPTER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133360
510(k) Type
Traditional
Applicant
AEROGEN LTD
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
10/17/2014
Days to Decision
350 days
Submission Type
Summary