510(k) K093712

FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM by Taidoc Technology Corporation — Product Code NBW

K093712 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 19, 2010. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has 122 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 19, 2010
Date Received
Dec 2, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type
510(k)

Source: FDA 510(k) database entry for K093712. Report a data issue: hello@regdatalab.com.