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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K781530
Device Name TEMPERATURE CONTROLLER MODEL 17000
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 Number868.5270
Classification Product Code
BZE  
Date Received09/06/1978
Decision Date 11/14/1978
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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