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 Recorder, Magnetic Tape, Medical
510(k) Number K862776
Device Name SPECTRUM POLYCORD I RECORDER SYSTEM
Applicant
Cardionics, Inc.
1100 Hercules, Suite 210
Houston,  TX  77058
Applicant Contact KEITH H JOHNSON
Correspondent
Cardionics, Inc.
1100 Hercules, Suite 210
Houston,  TX  77058
Correspondent Contact KEITH H JOHNSON
Regulation Number870.2800
Classification Product Code
DSH  
Date Received07/22/1986
Decision Date 08/18/1986
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
-
-