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 K970902
Device Name MEDILOG FD4
Applicant
Oxford Instruments Medical Systems
11526 53nd St. N
Clearwater,  FL  34620
Applicant Contact CHARLES HOLZ
Correspondent
Oxford Instruments Medical Systems
11526 53nd St. N
Clearwater,  FL  34620
Correspondent Contact CHARLES HOLZ
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/11/1997
Decision Date 05/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-