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 K915075
Device Name NEBULIZER (DIRECT PATIENT INTERFACE)
Applicant
MEDI NUCLEAR CORP., INC.
4501 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Applicant Contact RUSSELL W.KING
Correspondent
MEDI NUCLEAR CORP., INC.
4501 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Correspondent Contact RUSSELL W.KING
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/08/1991
Decision Date 07/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-