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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-dioxide, gaseous-phase
510(k) Number K841498
Device Name C02 MONITOR-OIR-7101
Applicant
NIHON KOHDEN AMERICA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NIHON KOHDEN AMERICA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/10/1984
Decision Date 05/14/1984
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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