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 Camera, Multi Format, Radiological
510(k) Number K962364
Device Name CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
Applicant
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Applicant Contact PETER BOTTEN
Correspondent
Codonics, Inc.
17991 Englewood Dr.
Middleburg Heights,  OH  44130
Correspondent Contact PETER BOTTEN
Regulation Number892.2040
Classification Product Code
LMC  
Date Received06/19/1996
Decision Date 11/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-