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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Volume, Gas
510(k) Number K853848
Device Name RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
Applicant
Medical Graphics Corp.
501 W. County Rd. E
St. Paul,  MN  55112
Applicant Contact RONALD BERGESON
Correspondent
Medical Graphics Corp.
501 W. County Rd. E
St. Paul,  MN  55112
Correspondent Contact RONALD BERGESON
Regulation Number868.1870
Classification Product Code
BXW  
Date Received09/16/1985
Decision Date 12/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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