• 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 Calculator, Predicted Values, Pulmonary Function
510(k) Number K080734
Device Name FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
Applicant
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG,  DE 97204
Applicant Contact THOMAS RUST
Correspondent
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG,  DE 97204
Correspondent Contact THOMAS RUST
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Code
DPS  
Date Received03/14/2008
Decision Date 06/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-