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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echoencephalograph
510(k) Number K921863
Device Name SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Applicant Contact CHARLES R BURR
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810 -1085
Correspondent Contact CHARLES R BURR
Regulation Number882.1240
Classification Product Code
GXW  
Date Received04/17/1992
Decision Date 09/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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