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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, Diagnostic
510(k) Number K940671
Device Name INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER
Applicant
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Applicant Contact ARTHUR J SCHENCK
Correspondent
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Correspondent Contact ARTHUR J SCHENCK
Regulation Number892.1570
Classification Product Code
ITX  
Date Received02/16/1994
Decision Date 11/22/1994
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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