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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, Enflurane, Gaseous-Phase (Anesthetic Concentration)
510(k) Number K911647
Device Name NGM GAS MODULE
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact VINCENT RAUSCHER
Correspondent
DATEX DIVISION INSTRUMENTARIUM CORP.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact VINCENT RAUSCHER
Regulation Number868.1500
Classification Product Code
CBQ  
Date Received04/15/1991
Decision Date 09/19/1991
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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