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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 K853990
Device Name OSM3 HEMOXIMETER
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Applicant Contact GERALD L VEDAA
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact GERALD L VEDAA
Regulation Number862.3220
Classification Product Code
JKS  
Date Received09/27/1985
Decision Date 12/30/1985
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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