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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
MUNCHEN,  DE D-82152
Applicant Contact TORSTEN SCHLICHTHOLZ
Correspondent
MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH
FRAUNHOFERSTRASSE 16
MUNCHEN,  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
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