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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 K892944
Device Name INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515
Applicant
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Applicant Contact ARTHUR SCHENCK
Correspondent
Interspec, Inc.
1100 E. Hector St.
Conshohocken,  PA  19428
Correspondent Contact ARTHUR SCHENCK
Regulation Number870.2880
Classification Product Code
JOP  
Date Received04/21/1989
Decision Date 07/19/1989
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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