The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Choice Voice+ Blood Glucose Monitoring System.
Device ID | K102049 |
510k Number | K102049 |
Device Name: | CLEVER CHOICE VOICE+ BLOOD GLUCOSE 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 | Teling Hsu |
Correspondent | Teling Hsu TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU TOWNSHIP Taipei County, TW 24888 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-21 |
Decision Date | 2011-05-27 |
Summary: | summary |