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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K923519
Device Name SENSOR GUI
Applicant
Hospitronic
12 Blvd. Des Lles
92130 Issy-Les-Moulineaux
France,  FR
Applicant Contact L. S MONTEJO
Correspondent
Hospitronic
12 Blvd. Des Lles
92130 Issy-Les-Moulineaux
France,  FR
Correspondent Contact L. S MONTEJO
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/30/1992
Decision Date 12/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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