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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 K802459
Device Name SIEMENS-ELEMA AB CO2 MONITOR 130
Applicant
SIEMENS ELEMA AB
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SIEMENS ELEMA AB
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/08/1980
Decision Date 10/23/1980
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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