510(k) K091814

FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE by Taidoc Technology Corporation — Product Code CGA

K091814 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE". The FDA issued a decision of Substantially Equivalent on Nov 20, 2009. The device falls under product code CGA (Glucose Oxidase, Glucose), 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
Nov 20, 2009
Date Received
Jun 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type
510(k)

Source: FDA 510(k) database entry for K091814. Report a data issue: hello@regdatalab.com.