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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 K001095
Device Name OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
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 Received04/04/2000
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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