The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Advocate Redi-code Blood Glucose Monitoring System, Models Td-4223e; Td-4223f.
Device ID | K072039 |
510k Number | K072039 |
Device Name: | ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F |
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 | 2007-07-25 |
Decision Date | 2007-10-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816042012747 | K072039 | 000 |
00816042012730 | K072039 | 000 |