• 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 K192210
Device Name ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
Applicant
Fiab SpA
Via Costoli, 4
vicchio,  IT 50039
Applicant Contact francesco batistini
Correspondent
Fiab SpA
Via Costoli, 4
vicchio,  IT 50039
Correspondent Contact francesco batistini
Regulation Number880.2910
Classification Product Code
FLL  
Subsequent Product Code
IKD  
Date Received08/14/2019
Decision Date 10/10/2019
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
-
-