FDA 510(k) Application Details - K033025

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K033025
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant TYTAN MEDICAL CORP.
1-3F, NO. 2, 1 LANE, JUANG
SHING RD. SEC. 1, WU GU 248
TAIPEI HSIEN, R.O.C. 248 TW
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Contact WILLIAM HSIEH
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/26/2003
Decision Date 12/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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