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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827209
Device Name SYSTEM 287 SCANNER
Applicant
Diagnostic Sonar USA
67079 Read Rd.
Cambridge,  OH  43725
Correspondent
Diagnostic Sonar USA
67079 Read Rd.
Cambridge,  OH  43725
Date Received03/01/1982
Decision Date 04/15/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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