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, With Electrical Conductors
510(k) Number K961060
Device Name ARISTO ESOPHAGEAL STETHOSCOPE
Applicant
ARISTO MEDICAL PRODUCTS, INC.
P.O. BOX 1637
WAUKESHA,  WI  53187 -2345
Applicant Contact STEPHEN H GORSKI
Correspondent
ARISTO MEDICAL PRODUCTS, INC.
P.O. BOX 1637
WAUKESHA,  WI  53187 -2345
Correspondent Contact STEPHEN H GORSKI
Regulation Number868.1920
Classification Product Code
BZT  
Date Received03/18/1996
Decision Date 06/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-