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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 K922184
Device Name HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
Applicant
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact PAMELA J WEAGRAFF
Correspondent
Hewlett-Packard Co.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact PAMELA J WEAGRAFF
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/11/1992
Decision Date 07/30/1992
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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