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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
510(k) Number K781871
Device Name DIFFUSION OPTION, OMNI-LAB
Applicant
Ohio Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ohio Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received11/03/1978
Decision Date 01/02/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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