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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K924575
Device Name ATLANTIS GUI
Applicant
Hospitronics
12 Blvd. Des Lles
9210 Issy-Les-Moulineaux
France,  FR
Applicant Contact MONTEJO
Correspondent
Hospitronics
12 Blvd. Des Lles
9210 Issy-Les-Moulineaux
France,  FR
Correspondent Contact MONTEJO
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/10/1992
Decision Date 03/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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