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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, breathing frequency
510(k) Number K901466
Device Name MESAMIV RECORDER
Applicant
MADAUS MEDTEC, INC.
901 BETHLEHEM PIKE
SPRING HOUSE,  PA  19902
Applicant Contact MAHONY
Correspondent
MADAUS MEDTEC, INC.
901 BETHLEHEM PIKE
SPRING HOUSE,  PA  19902
Correspondent Contact MAHONY
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/28/1990
Decision Date 06/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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