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, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K841469
Device Name MISTY OX DISPOS. NEBULIZER
Applicant
Medical Molding Corp. of America
1611 Babcock
Newport Beach,  CA  92663
Applicant Contact Terry Bagwell
Correspondent
Medical Molding Corp. of America
1611 Babcock
Newport Beach,  CA  92663
Correspondent Contact Terry Bagwell
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received04/09/1984
Decision Date 04/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-