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, Patient Position, Light-Beam
510(k) Number K893398
Device Name CENTRALITE BACKPOINTER
Applicant
Diacor, Inc.
3191 S. 3300 E.,
Suite 100-A
Salt Lake City,  UT  84109
Applicant Contact N WATERMAN
Correspondent
Diacor, Inc.
3191 S. 3300 E.,
Suite 100-A
Salt Lake City,  UT  84109
Correspondent Contact N WATERMAN
Regulation Number892.5780
Classification Product Code
IWE  
Date Received05/01/1989
Decision Date 08/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-