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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 K993641
Device Name METALYZER, MODEL 2; METALYZER, MODEL 3
Applicant
Cortex Biophysik GmbH
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ART WARD
Correspondent
Cortex Biophysik GmbH
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ART WARD
Regulation Number868.1890
Classification Product Code
BTY  
Date Received10/28/1999
Decision Date 12/14/2000
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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