510(k) K061073

CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250 by Taidoc Technology Corporation — Product Code DXN

K061073 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250". The FDA issued a decision of Substantially Equivalent on Jun 2, 2006. 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
Jun 2, 2006
Date Received
Apr 17, 2006
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 K061073. Report a data issue: hello@regdatalab.com.