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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 K842325
Device Name CAPNOMETER
Applicant
SENSORS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SENSORS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/13/1984
Decision Date 06/26/1984
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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