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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K925078
Device Name SPECTRADOP
Applicant
Bennett and Assoc., Inc.
67079 Read Rd.
Cambridge,  OH  43725
Applicant Contact JOHN B BENNETT
Correspondent
Bennett and Assoc., Inc.
67079 Read Rd.
Cambridge,  OH  43725
Correspondent Contact JOHN B BENNETT
Regulation Number870.2880
Classification Product Code
JOP  
Subsequent Product Codes
DSB   JOM  
Date Received10/07/1992
Decision Date 07/17/1995
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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