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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K913997
Device Name SAECG CARDIOGRAPH MODEL M1754A
Applicant
Hewlett-Packard Co.
1700 S. Baker St.
Mcminnville,  OR  97128
Applicant Contact MONICA FERRANTE
Correspondent
Hewlett-Packard Co.
1700 S. Baker St.
Mcminnville,  OR  97128
Correspondent Contact MONICA FERRANTE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/06/1991
Decision Date 03/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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