The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Poct Managment System.
Device ID | K111029 |
510k Number | K111029 |
Device Name: | FORA POCT MANAGMENT SYSTEM |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County, TW 24888 |
Contact | Teling Hsu |
Correspondent | Teling Hsu TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD. WUGU TOWNSHIP Taipei County, TW 24888 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-13 |
Decision Date | 2011-07-01 |
Summary: | summary |