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 Transducer, Ultrasonic, Diagnostic
510(k) Number K902728
Device Name 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
Applicant
Ausonics Pty , Ltd.
40 Crane Hill Rd.
Suffield,  CT  06078
Applicant Contact WILLIAM NEALON
Correspondent
Ausonics Pty , Ltd.
40 Crane Hill Rd.
Suffield,  CT  06078
Correspondent Contact WILLIAM NEALON
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/21/1990
Decision Date 02/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-