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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 K955013
Device Name NOVA CO-OXIMETER ANALYZER
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 Received11/01/1995
Decision Date 04/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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