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 K201490
Device Name Electro Flo 6 Airway Clearance System
Applicant
Med Systems, Inc.
2631 Ariane Drive
San Diego,  CA  92117
Applicant Contact Susan B Davis
Correspondent
BioMedical Strategies
133 Colonial Dr.
White River Junction,  VT  05001
Correspondent Contact Frederick Cahn
Regulation Number868.5665
Classification Product Code
BYI  
Date Received06/04/2020
Decision Date 02/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-