The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-1035 Thermometer.
Device ID | K152680 |
510k Number | K152680 |
Device Name: | TD-1035 Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | TAIDOC TECHNOLOGY CORPORATION 6F, NO. 127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
Contact | C.w Chen |
Correspondent | Sharon Peng TAIDOC TECHNOLOGY CORPORATION 6F, NO. 127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-18 |
Decision Date | 2016-05-06 |
Summary: | summary |