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 System, Image Processing, Radiological
510(k) Number K002724
Device Name NUMALINK
Applicant
NUMA, INC.
10 NORTHERN BLVD., UNIT 12
AMHERST,  NH  03031
Applicant Contact LARRY SMITH
Correspondent
NUMA, INC.
10 NORTHERN BLVD., UNIT 12
AMHERST,  NH  03031
Correspondent Contact LARRY SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/31/2000
Decision Date 11/17/2000
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
-
-