510(k) K073445

CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 by Taidoc Technology Corporation — Product Code DXN

K073445 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026". The FDA issued a decision of Substantially Equivalent on Apr 2, 2008. 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
Apr 2, 2008
Date Received
Dec 7, 2007
Clearance Type
Special
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 K073445. Report a data issue: hello@regdatalab.com.