The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for V-trust Td-8002 Multi-parameter Spot-check Monitor Model Td-8002.
Device ID | K101259 |
510k Number | K101259 |
Device Name: | V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
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 | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-04 |
Decision Date | 2010-06-17 |
Summary: | summary |