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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K823683
Device Name VITALOGRAPH PFT PRINTER
Applicant
VITALOGRAPH LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VITALOGRAPH LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1890
Classification Product Code
BTY  
Date Received12/07/1982
Decision Date 01/21/1983
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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