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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 STREET, N.W.
SUITE 500 NORTH
WASHINGTON,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
TELEDYNE BROWN ENGINEERING
601 13TH STREET, N.W.
SUITE 500 NORTH
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
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