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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K772350
Device Name PATIENT ALERT MODEL 555
Applicant
INTERMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INTERMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.2920
Classification Product Code
DXH  
Date Received12/23/1977
Decision Date 03/09/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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