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 Percussor, Powered-Electric
510(k) Number K132794
Device Name SMARTVEST AIRWAY CLEARANCE SYSTEM
Applicant
ELECTROMED, INC.
502 SIXTH AVE. N.W.
NEW PRAGUE,  MN  56071
Applicant Contact CHET SIEVERT
Correspondent
ELECTROMED, INC.
502 SIXTH AVE. N.W.
NEW PRAGUE,  MN  56071
Correspondent Contact CHET SIEVERT
Regulation Number868.5665
Classification Product Code
BYI  
Date Received09/06/2013
Decision Date 12/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-