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 Monitor, Ultrasonic, Nonfetal
510(k) Number K982635
Device Name CAREDOP II
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 Number892.1540
Classification Product Code
JAF  
Date Received07/13/1998
Decision Date 08/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-