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 Nebulizer (Direct Patient Interface)
510(k) Number K201167
Device Name AireHealth NebulizerTM
Applicant
Airehealth, Inc.
3251 Progess Dr., Suite F
Orlando,  FL  32826
Applicant Contact Rusty Kelly
Correspondent
Regulatory and Quality Solutions, LLC
2790 Mosside Blvd. #800
Monroeville,  PA  15146
Correspondent Contact Jessica Czamanski
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/01/2020
Decision Date 12/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-