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 System, Monitoring, Perinatal
510(k) Number K780176
Device Name DISPLAY SYSTEM MODEL 428
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2740
Classification Product Code
HGM  
Date Received02/03/1978
Decision Date 03/02/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-