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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K840526
Device Name AMETHERM
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 Number880.5400
Classification Product Code
FMZ  
Date Received02/07/1984
Decision Date 04/30/1984
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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