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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K953218
Device Name AUSCULATOR GPS
Applicant
Lyte Industries, Inc.
210 Waterlod Bldg.
531 Commercial St.
Waterloo,  IA  50701
Applicant Contact CHARLES E GRASSLEY
Correspondent
Lyte Industries, Inc.
210 Waterlod Bldg.
531 Commercial St.
Waterloo,  IA  50701
Correspondent Contact CHARLES E GRASSLEY
Regulation Number870.1875
Classification Product Code
DQD  
Date Received07/10/1995
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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