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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 K930278
Device Name STORZ COMPUSCAN AB
Applicant
Storz
3365 Tree Ct. Industrial
Boulevard
St. Louis,  MO  63122
Applicant Contact MICHAEL T TAGGART
Correspondent
Storz
3365 Tree Ct. Industrial
Boulevard
St. Louis,  MO  63122
Correspondent Contact MICHAEL T TAGGART
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/21/1993
Decision Date 02/09/1994
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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