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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 K821735
Device Name TROPIC AIR HEAT-ECHANGER BREATHING AID
Applicant
TROPIC AIR
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TROPIC AIR
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5270
Classification Product Code
BZE  
Date Received06/14/1982
Decision Date 09/07/1982
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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