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 stethoscope, esophageal
510(k) Number K874519
Device Name MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
Applicant
MON-A-THERM, INC.
ST. LOUIS BUSINESS CENTER
500 SOUTH EWING AVENUE
ST. LOUIS,  MO  63103
Applicant Contact ALAN T BECKMAN
Correspondent
MON-A-THERM, INC.
ST. LOUIS BUSINESS CENTER
500 SOUTH EWING AVENUE
ST. LOUIS,  MO  63103
Correspondent Contact ALAN T BECKMAN
Regulation Number868.1910
Classification Product Code
BZW  
Date Received11/02/1987
Decision Date 01/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-