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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K093080
Device Name METAPHOR METABOLIC MONITOR
Applicant
Treymed, Inc.
N56 W24790 N. Corporate Circle
Unit C
Sussex,  WI  53089
Applicant Contact ROBERT H RICCIARDELLI
Correspondent
Treymed, Inc.
N56 W24790 N. Corporate Circle
Unit C
Sussex,  WI  53089
Correspondent Contact ROBERT H RICCIARDELLI
Regulation Number868.1730
Classification Product Code
BZL  
Subsequent Product Codes
BZC   CBR   CCK   CCL   DQA  
Date Received09/30/2009
Decision Date 01/22/2010
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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