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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K083874
Device Name GALAXY
Applicant
Respironics Inc., Sleep & Home Respiratory Group
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact ANDREW P ZELTWANGER
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/29/2008
Decision Date 01/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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