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 K013281
Device Name VERSALAB APM
Applicant
Nicolet Biomedical
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact DAVID W WAGNER
Correspondent
Nicolet Biomedical
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact DAVID W WAGNER
Regulation Number884.2740
Classification Product Code
HGM  
Date Received10/02/2001
Decision Date 04/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-