The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Gd43 Blood Glucose Monitoring System.
Device ID | K143467 |
510k Number | K143467 |
Device Name: | FORA GD43 Blood Glucose Monitoring System |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
Contact | C. W. Chen |
Correspondent | Paul Liu TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, 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 | 2014-12-04 |
Decision Date | 2015-05-07 |
Summary: | summary |