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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K993094
Device Name AERO-CLICK
Applicant
Map Medizintechnik Fur Arzt Und Patient GmbH
Fraunhoferstrasse 16
Martinsried,  DE D-82152
Applicant Contact TORSTEN SCHLICHTHOLZ
Correspondent
Map Medizintechnik Fur Arzt Und Patient GmbH
Fraunhoferstrasse 16
Martinsried,  DE D-82152
Correspondent Contact TORSTEN SCHLICHTHOLZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/16/1999
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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