510(k) K101259

V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 by Taidoc Technology Corporation — Product Code MWI

K101259 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002". The FDA issued a decision of Substantially Equivalent on Jun 17, 2010. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Taidoc Technology Corporation has 122 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 17, 2010
Date Received
May 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K101259. Report a data issue: hello@regdatalab.com.