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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
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