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 K950288
Device Name AUTOLASER MULTI FORMAT CAMERA
Applicant
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Applicant Contact DAVID VOZICK
Correspondent
Afp Imaging Corp.
250 Clearbrook Rd.
Elmsford,  NY  10523
Correspondent Contact DAVID VOZICK
Regulation Number892.2040
Classification Product Code
LMC  
Date Received01/25/1995
Decision Date 04/04/1995
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
-
-