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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K812977
Device Name RESPIRATORY CARE MONITOR
Applicant
Advanced Medical Equipment, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Advanced Medical Equipment, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5810
Classification Product Code
BZA  
Date Received10/23/1981
Decision Date 11/16/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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