Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Continuous Measurement Thermometer
510(k) Number K240333
Device Name Wearable Digital Thermometer (T31)
Applicant
Guangdong Genial Technology Co., Ltd.
I-6-05-02 11th Rd., Area B, Guangfozhao Economic
Cooperation Zone, Zhagang Town, Huaiji County
Zhaoqing,  CN 526437
Applicant Contact Jun Yu
Correspondent
Constant Medical Technology Co., Ltd.
# 2021-6, 2nd Floor, # 228 Huadi Ave. Middle
Liwan District, Guangzhou
Zhaoqing,  CN 526437
Correspondent Contact Klem Hou
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/05/2024
Decision Date 10/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-