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 K904196
Device Name MICRO-MIST NEBULIZER
Applicant
BP LTD.
P.O. BOX 3052
MIDDLETOWN,  NY  10940
Applicant Contact KATHLEEN BORDONI
Correspondent
BP LTD.
P.O. BOX 3052
MIDDLETOWN,  NY  10940
Correspondent Contact KATHLEEN BORDONI
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/12/1990
Decision Date 12/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-