• 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 audiometer
510(k) Number K970555
Device Name IL0292 DP ECHOPORT
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact E. J SMITH
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number874.1050
Classification Product Code
Date Received02/13/1997
Decision Date 03/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No