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 K903992
Device Name CYGNET CENTRAL
Applicant
Cygnet Co., Inc.
844 Jury Ct.
San Jose,  CA  95112
Applicant Contact RUDAIN ARAFEH
Correspondent
Cygnet Co., Inc.
844 Jury Ct.
San Jose,  CA  95112
Correspondent Contact RUDAIN ARAFEH
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/29/1990
Decision Date 12/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-