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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Analytical Sampling
510(k) Number K011238
Device Name RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
Applicant
Metracor Technologies, Inc.
11425 Sorrento Valley Rd.
San Diego,  CA  92121
Applicant Contact GEORGE F MCHUGH
Correspondent
Metracor Technologies, Inc.
11425 Sorrento Valley Rd.
San Diego,  CA  92121
Correspondent Contact GEORGE F MCHUGH
Regulation Number880.5725
Classification Product Code
LZF  
Date Received04/23/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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