The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Echo Td-3227 Dual Blood Pressure/blood Glucose Meter.
Device ID | K092875 |
510k Number | K092875 |
Device Name: | ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER |
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 | Debra Liang |
Correspondent | Debra Liang 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-18 |
Decision Date | 2010-08-13 |
Summary: | summary |