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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 K810712
Device Name ELECTRONIC SPIROMETER MODEL MFR-8100
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Regulation Number868.1890
Classification Product Code
BTY  
Date Received03/17/1981
Decision Date 03/24/1981
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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