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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
MONROEVILLE,  PA  15146
Applicant Contact JOSEPH E OLSAVSKY
Correspondent
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  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
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