510(k) K101569

V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER by Taidoc Technology Corporation — Product Code DPS

K101569 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER". The FDA issued a decision of Substantially Equivalent on Mar 1, 2011. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Taidoc Technology Corporation has 122 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 1, 2011
Date Received
Jun 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K101569. Report a data issue: hello@regdatalab.com.