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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 K821731
Device Name HEALTHDYNE MODEL 16900 INFANT MONITOR
Applicant
HEALTHDYNE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HEALTHDYNE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received06/01/1982
Decision Date 07/13/1982
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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