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 Neurological Stereotaxic Instrument
510(k) Number K001431
Device Name MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Applicant Contact KEVIN J O'CONNELL
Correspondent
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Correspondent Contact KEVIN J O'CONNELL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/08/2000
Decision Date 05/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
-
-