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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K110398
Device Name RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
Applicant
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Applicant Contact JOSEPH E OLSAVSKY
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Correspondent Contact JOSEPH E OLSAVSKY
Regulation Number868.5270
Classification Product Code
BZE  
Date Received02/11/2011
Decision Date 06/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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