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510(k) K141140

COMP A-I-R by Omron Healthcare, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2014
Date Received
May 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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