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 K963174
Device Name HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606 -4801
Applicant Contact RAPHAEL HENKIN, PH.D.
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606 -4801
Correspondent Contact RAPHAEL HENKIN, PH.D.
Regulation Number870.2800
Classification Product Code
DSH  
Date Received08/14/1996
Decision Date 03/13/1997
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
-
-