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 thermometer, electronic, clinical
510(k) Number K172508
Device Name Ageless Health Medical Digital Thermometer
Applicant
Ageless Health Industrial Co., Ltd
3/F, A1 Bldg, Dongshen Sima Industrial Area,
No.33 Shenbei Road, Sima Village,
Dongguan,  CN 523000
Applicant Contact Victor Wan
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, No.121 Science Road
Guangzhou Science Park
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/21/2017
Decision Date 08/08/2018
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
-
-