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 Coil, Magnetic Resonance, Specialty
510(k) Number K120122
Device Name SENSE MSK S 8CH 1.5T
Applicant
Invivo Corporation
3545 SW 47th Ave.
Florida,  FL  32608
Applicant Contact Lisa Simpson
Correspondent
Invivo Corporation
3545 SW 47th Ave.
Florida,  FL  32608
Correspondent Contact Lisa Simpson
Regulation Number892.1000
Classification Product Code
MOS  
Date Received01/17/2012
Decision Date 02/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-