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 K863231
Device Name D100 COMPUTER CARDIAC ANALYSIS SYSTEM
Applicant
Dextra Medical, Inc.
4031 Via Oro Ave.
Long Beach,  CA  90810
Applicant Contact SLAWOMIR LOBODZINSKI
Correspondent
Dextra Medical, Inc.
4031 Via Oro Ave.
Long Beach,  CA  90810
Correspondent Contact SLAWOMIR LOBODZINSKI
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/21/1986
Decision Date 11/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-