• 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, obstetric
510(k) Number K872265
Device Name ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
Applicant
LABSONICS, INC.
P.O. BOX 337
236 E. WASHINGTON ST.
MOORESVILLE,  IN  46158
Applicant Contact N. T SANGHVI
Correspondent
LABSONICS, INC.
P.O. BOX 337
236 E. WASHINGTON ST.
MOORESVILLE,  IN  46158
Correspondent Contact N. T SANGHVI
Regulation Number884.2960
Classification Product Code
HGL  
Date Received06/11/1987
Decision Date 01/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-