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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 K024155
Device Name MX 300 OXYGEN MONITOR
Applicant
TELEDYNE ANALYTICAL INSTRUMENTS
16830 CHESTNUT ST.
CITY OF INDUSTRY,  CA  91749
Applicant Contact RAY KHAJAVI
Correspondent
TELEDYNE ANALYTICAL INSTRUMENTS
16830 CHESTNUT ST.
CITY OF INDUSTRY,  CA  91749
Correspondent Contact RAY KHAJAVI
Regulation Number868.1720
Classification Product Code
CCL  
Date Received12/17/2002
Decision Date 07/17/2003
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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