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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 K894641
Device Name MESAM 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 Received07/24/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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