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 K894215
Device Name EVOLUTION ULTRASONIC
Applicant
MEDICAL INDUSTRIES AMERICA, INC.
713 - 52ND ST.
WEST DES MOINES,  IA  50265
Applicant Contact RUSSELL BIRD
Correspondent
MEDICAL INDUSTRIES AMERICA, INC.
713 - 52ND ST.
WEST DES MOINES,  IA  50265
Correspondent Contact RUSSELL BIRD
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received06/19/1989
Decision Date 04/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-