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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 K834335
Device Name AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
Applicant
Egnell, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Egnell, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5700
Classification Product Code
LBI  
Date Received12/12/1983
Decision Date 04/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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