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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K892354
Device Name ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
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 Number884.2740
Classification Product Code
HGM  
Date Received03/10/1989
Decision Date 08/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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