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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 K131245
Device Name OREGON SCINTIFIC
Applicant
Idt Technology Limited
Block 33, Idt Technology Limited,
Chentian Industrial Estate, Xixiang, Baoan
Shenzhen,,  CN CH
Applicant Contact LILY LI
Correspondent
Idt Technology Limited
Block 33, Idt Technology Limited,
Chentian Industrial Estate, Xixiang, Baoan
Shenzhen,,  CN CH
Correspondent Contact LILY LI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/01/2013
Decision Date 01/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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