The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Model Td-3252 Blood Glucose Plus Blood Pressure Monitoring System.
Device ID | K091555 |
510k Number | K091555 |
Device Name: | MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
Contact | Erica Li |
Correspondent | Erica Li TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
Product Code | NBW |
Subsequent Product Code | CGA |
Subsequent Product Code | DXN |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-27 |
Decision Date | 2010-03-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816042011610 | K091555 | 000 |