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 Device, Digital Image Storage, Radiological
510(k) Number K882184
Device Name HR-1000 W/SUFFIXES (B,C OR D)
Applicant
EIGEN
P.O. BOX 848
NEVADA CITY,  CA  95959
Applicant Contact MARK A HOFFMAN
Correspondent
EIGEN
P.O. BOX 848
NEVADA CITY,  CA  95959
Correspondent Contact MARK A HOFFMAN
Regulation Number892.2010
Classification Product Code
LMB  
Date Received05/24/1988
Decision Date 06/28/1988
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
-
-