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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 -8599
Applicant Contact KATHRYN A NEUMANN
Correspondent
MEDICAL GRAPHICS CORP.
350 OAK GROVE PKWY.
ST. PAUL,  MN  55127 -8599
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
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