The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Revolution Td-4229 Blood Glucose Monitoring System.
Device ID | K072489 |
510k Number | K072489 |
Device Name: | REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Contact | Erica Li |
Correspondent | Erica Li TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-04 |
Decision Date | 2007-09-20 |