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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K963177
Device Name TED 191
Applicant
Teledyne Brown Engineering
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
Teledyne Brown Engineering
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/14/1996
Decision Date 11/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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