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 K023618
Device Name SONICAID ONE
Applicant
Oxford Instruments Medical , Ltd.
Manor Way
Old Woking, Surrey,  GB GU22 9JU
Applicant Contact MICHAEL EDWARDS
Correspondent
Oxford Instruments Medical , Ltd.
Manor Way
Old Woking, Surrey,  GB GU22 9JU
Correspondent Contact MICHAEL EDWARDS
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received10/29/2002
Decision Date 01/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-