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 Spirometer, Therapeutic (Incentive)
510(k) Number K033401
Device Name MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
Applicant
ADVANCED CIRCULATORY SYSTEMS, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
ADVANCED CIRCULATORY SYSTEMS, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number868.5690
Classification Product Code
BWF  
Subsequent Product Code
JOW  
Date Received10/24/2003
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-