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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K890173
Device Name INTERSPEC APOGEE
Applicant
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Applicant Contact E THOMENIUS
Correspondent
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Correspondent Contact E THOMENIUS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/17/1989
Decision Date 04/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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