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 knife, ear
510(k) Number K910212
Device Name COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
Applicant
ACOUSTIC IMAGING TECHNOLOGIES CORP.
10027 SOUTH 15ST ST.
PHOENIX,  AZ  85044
Applicant Contact LORI CADWELL
Correspondent
ACOUSTIC IMAGING TECHNOLOGIES CORP.
10027 SOUTH 15ST ST.
PHOENIX,  AZ  85044
Correspondent Contact LORI CADWELL
Regulation Number874.4420
Classification Product Code
JYO  
Date Received01/15/1991
Decision Date 07/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-