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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
510(k) Number K863825
Device Name CO-OXIMETER SOLUTIONS
Applicant
D.R.G. Scientific Industries
1140 Saratoga St.
East Boston,  MA  02128
Applicant Contact VINCENT E CORSANO
Correspondent
D.R.G. Scientific Industries
1140 Saratoga St.
East Boston,  MA  02128
Correspondent Contact VINCENT E CORSANO
Regulation Number862.3220
Classification Product Code
JKS  
Date Received09/30/1986
Decision Date 11/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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