The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora D40 Blood Glucose Plus Blood Pressure Monitoring System.
Device ID | K101926 |
510k Number | K101926 |
Device Name: | FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING 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 | Linda Ko |
Correspondent | Linda Ko TaiDoc Technology Corporation 3F,5F, 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 | 2010-07-09 |
Decision Date | 2011-12-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816042013447 | K101926 | 000 |
00816042011771 | K101926 | 000 |
00816042013959 | K101926 | 000 |
00850001002011 | K101926 | 000 |
00816042011009 | K101926 | 000 |
00816042012044 | K101926 | 000 |
00816042012846 | K101926 | 000 |
00816042012853 | K101926 | 000 |
00816042013256 | K101926 | 000 |
00816042014628 | K101926 | 000 |