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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, oxygen, gaseous-phase
510(k) Number K822608
Device Name MK 808 SERIES NASAL OXYGEN SAMPLER
Applicant
INSTRUMENTATION INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSTRUMENTATION INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/30/1982
Decision Date 10/04/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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