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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter To Measure Hemoglobin
510(k) Number K993104
Device Name STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
Applicant
Nova Biomedical Corp.
200 Prospect St.
Walham,  MA  02454
Applicant Contact PAUL W MAC DONALD
Correspondent
Nova Biomedical Corp.
200 Prospect St.
Walham,  MA  02454
Correspondent Contact PAUL W MAC DONALD
Regulation Number864.7500
Classification Product Code
GLY  
Date Received09/16/1999
Decision Date 12/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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