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 K894961
Device Name MEDISONIC ULTRA-SONIC INHALER
Applicant
MEDISONIC U.S.A., INC.
9600 MAIN ST.
CLARENCE,  NY  14031
Applicant Contact DON TRAINER
Correspondent
MEDISONIC U.S.A., INC.
9600 MAIN ST.
CLARENCE,  NY  14031
Correspondent Contact DON TRAINER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/07/1989
Decision Date 11/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-