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510(k) K161719

Salter Labs Bubble Humidifier by Salter Labs — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2017
Date Received
June 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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