The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for V-trust Model Td-2202 Portable Ecg Recorder.
Device ID | K101569 |
510k Number | K101569 |
Device Name: | V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER |
Classification | Electrocardiograph |
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 | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-04 |
Decision Date | 2011-03-01 |
Summary: | summary |