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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K823555
Device Name MAGTARAK RESPIRATORY MONITOR & FLOW SENS
Applicant
PENLON, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PENLON, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1850
Classification Product Code
BZK  
Date Received12/01/1982
Decision Date 01/05/1983
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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