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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
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