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510(k) K160540

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM by Flexicare Medical Limited. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2016
Date Received
February 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

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  • K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit (September 14, 2017)
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  • K151303 — AirLife Infant Heated Wire Circuit (January 21, 2016)