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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K903414
Device Name TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
Applicant
Echo Ultrasound
R.D. 2, Box 118
Reedsville,  PA  17084
Applicant Contact DAVID SZCZUPAKOWSKI
Correspondent
Echo Ultrasound
R.D. 2, Box 118
Reedsville,  PA  17084
Correspondent Contact DAVID SZCZUPAKOWSKI
Regulation Number870.2330
Classification Product Code
DXK  
Date Received07/30/1990
Decision Date 09/19/1990
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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