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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K903839
Device Name INTERSPEC APOGEE
Applicant
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Applicant Contact KAI E THOMENIUS
Correspondent
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Correspondent Contact KAI E THOMENIUS
Regulation Number870.2330
Classification Product Code
DXK  
Date Received08/21/1990
Decision Date 11/16/1990
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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