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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 K842597
Device Name RESPIRATORY GAS HUMIDIFIER
Applicant
APPLINC
7677 RONSON RD STE 108
SAN DIEGO,  CA  92102
Applicant Contact RICARDO AVIL
Correspondent
APPLINC
7677 RONSON RD STE 108
SAN DIEGO,  CA  92102
Correspondent Contact RICARDO AVIL
Regulation Number868.5270
Classification Product Code
BZE  
Date Received07/03/1984
Decision Date 01/16/1985
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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