510(k) K092106

U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 by Taidoc Technology Corporation — Product Code DXN

K092106 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132". The FDA issued a decision of Substantially Equivalent on Jan 25, 2010. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Taidoc Technology Corporation has 122 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 25, 2010
Date Received
Jul 14, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K092106. Report a data issue: hello@regdatalab.com.