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 K253162
Device Name Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
Applicant
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan D
Shenzhen,  CN 518108
Applicant Contact Huanyu Zeng
Correspondent
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan, Baoan D
Shenzhen,  CN 518108
Correspondent Contact Huanyu Zeng
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/26/2025
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-