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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K081800
Device Name T12S TELEMETRY TRANSMITTER
Original Applicant
MORTARA INSTRUMENT, INC.
7865 north 86th st.
milwaukee,  WI  53224
Original Contact laura spiegelhoff
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/25/2008
Decision Date 09/24/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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