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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K040576
Device Name MICROMESAM BASIC-SET
Applicant
Map Medizintechnik Fur Arzt Und Patient GmbH
14040 Danielson St.
Poway,  CA  92064
Applicant Contact DAVID D'CRUZ
Correspondent
Map Medizintechnik Fur Arzt Und Patient GmbH
14040 Danielson St.
Poway,  CA  92064
Correspondent Contact DAVID D'CRUZ
Regulation Number868.2375
Classification Product Code
MNR  
Date Received03/04/2004
Decision Date 07/01/2004
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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