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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Pressure
510(k) Number K943259
Device Name 1085 ULTIMATE E PLETHYSMOGRAPH
Applicant
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Applicant Contact KATHRYN A NEUMANN
Correspondent
Medical Graphics Corp.
350 Oak Grove Pkwy.
St. Paul,  MN  55127
Correspondent Contact KATHRYN A NEUMANN
Regulation Number868.1750
Classification Product Code
CCM  
Subsequent Product Code
BZC  
Date Received07/06/1994
Decision Date 04/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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