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 Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K212529
Device Name Hypotension Decision Assist Model HDA-OR2
Applicant
Directed Systems, Ltd.
47-51 Norfolk St.
Cambridge,  GB CB1 2LD
Applicant Contact Mark S. Leaning
Correspondent
Directed Systems, Ltd.
47-51 Norfolk St.
Cambridge,  GB CB1 2LD
Correspondent Contact Mark S. Leaning
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/11/2021
Decision Date 11/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-