The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Vtrust Finger Type Pulse Oximeter.
Device ID | K110893 |
510k Number | K110893 |
Device Name: | VTRUST FINGER TYPE PULSE OXIMETER |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-30 |
Decision Date | 2011-11-22 |
Summary: | summary |