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, vibration threshold measurement
510(k) Number K072882
Device Name PAIN VISION, MODEL PS-2100
Applicant
OSACHI CO., LTD.
3027 E. SUNSET RD., SUITE 105
LAS VEGAS,  NV  89120
Applicant Contact JAMES R GREENWOOD
Correspondent
OSACHI CO., LTD.
3027 E. SUNSET RD., SUITE 105
LAS VEGAS,  NV  89120
Correspondent Contact JAMES R GREENWOOD
Regulation Number882.1200
Classification Product Code
LLN  
Date Received10/09/2007
Decision Date 01/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-