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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K092893
Device Name TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
Applicant
Tytan Medical Corp.
No 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
Tytan Medical Corp.
No 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/21/2009
Decision Date 01/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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