Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K143719
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K143719
Device Name
Nebulizer (Direct Patient Interface)
Applicant
Aerogen Limited
Galway Business Park, Dangan
Galway IE
Other 510(k) Applications for this Company
Contact
Martin Crehan
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
CAF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/29/2014
Decision Date
07/10/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact