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 K863922
Device Name VERSAFLEX(TM) DELTA ST(TM) MONITOR
Applicant
Versaflex Delivery Systems, Inc.
4060-B Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact SOLAR, PHD
Correspondent
Versaflex Delivery Systems, Inc.
4060-B Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact SOLAR, PHD
Regulation Number870.2800
Classification Product Code
DSH  
Date Received10/08/1986
Decision Date 10/20/1986
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
-
-