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 monitor, blood-gas, on-line, cardiopulmonary bypass
510(k) Number K202557
Device Name Quantum Workstation 12 Elite
Applicant
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Applicant Contact Colleen Powell
Correspondent
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Correspondent Contact Colleen Powell
Regulation Number870.4330
Classification Product Code
DRY  
Date Received09/03/2020
Decision Date 10/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-