The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for No-coding Blood Glucose Monitoring System, Models Td-4251, Td-4252, Td-4253 And Td-4254.
Device ID | K092099 |
510k Number | K092099 |
Device Name: | NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
Contact | Debra Liang |
Correspondent | Debra Liang TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-14 |
Decision Date | 2009-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
80816042013917 | K092099 | 000 |