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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K892355
Device Name M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ
Applicant
Hewlett-Packard Co.
Schuckardstrabe 4
7030 Boblingen
Germany,  DE
Applicant Contact ERNST SCHALK
Correspondent
Hewlett-Packard Co.
Schuckardstrabe 4
7030 Boblingen
Germany,  DE
Correspondent Contact ERNST SCHALK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/17/1989
Decision Date 07/24/1989
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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