The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Digital Thermomter.
Device ID | K122520 |
510k Number | K122520 |
Device Name: | DIGITAL THERMOMTER |
Classification | Thermometer, Electronic, Clinical |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
Contact | Pinjung Chen |
Correspondent | Pinjung Chen 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 | 2012-08-17 |
Decision Date | 2013-02-05 |
Summary: | summary |