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 K193140
Device Name Flex Body SPEEDER
Applicant
Quality Electrodynamics, LLC
6655 Beta Drive Suite 100
Mayfield Village,  OH  44143
Applicant Contact Eric Yeh
Correspondent
Quality Electrodynamics, LLC
6655 Beta Drive Suite 100
Mayfield Village,  OH  44143
Correspondent Contact Eric Yeh
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/13/2019
Decision Date 01/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-