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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K070180
Device Name WALLABY 4
Applicant
Respironics Inc., Sleep & Home Respiratory Group
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact ZITA A YURKO
Correspondent
Respironics Inc., Sleep & Home Respiratory Group
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact ZITA A YURKO
Regulation Number880.5700
Classification Product Code
LBI  
Date Received01/19/2007
Decision Date 05/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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