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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K873521
Device Name BRONCHODILATOR TEE - 9056 SERIES
Applicant
BOEHRINGER LABORATORIES
P.O. BOX 870
NORRISTOWN,  PA  19404
Applicant Contact JOHN R BOEHRINGER
Correspondent
BOEHRINGER LABORATORIES
P.O. BOX 870
NORRISTOWN,  PA  19404
Correspondent Contact JOHN R BOEHRINGER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/01/1987
Decision Date 03/02/1988
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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