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510(k) K162553

AirSpiral Heated Breathing Tube by Fisher & Paykel Health Care — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2018
Date Received
September 13, 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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  • K162582 — HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit (June 23, 2017)

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