• 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, With Electrical Conductors
510(k) Number K852228
Device Name ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
Applicant
SENSORTEK, INC.
154 HURON AVE.
CLIFTON,  NJ  07013
Applicant Contact RONALD R FELLER
Correspondent
SENSORTEK, INC.
154 HURON AVE.
CLIFTON,  NJ  07013
Correspondent Contact RONALD R FELLER
Regulation Number868.1920
Classification Product Code
BZT  
Date Received05/22/1985
Decision Date 09/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-