The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Health Care System Software.
Device ID | K110948 |
510k Number | K110948 |
Device Name: | HEALTH CARE SYSTEM SOFTWARE |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP New Taipei County, TW 24888 |
Contact | Teling Hsu |
Correspondent | Teling Hsu TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP New Taipei County, TW 24888 |
Product Code | NBW |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-04 |
Decision Date | 2011-05-13 |
Summary: | summary |