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 K970844
Device Name ATOMISOR
Applicant
MEDICAL CONSULTING SERVICE, INC.
658 DOUGLAS AVENUE,SUITE 1110
ALTAMONTE SPRINGS,  FL  32714
Applicant Contact CHERYL WARD
Correspondent
MEDICAL CONSULTING SERVICE, INC.
658 DOUGLAS AVENUE,SUITE 1110
ALTAMONTE SPRINGS,  FL  32714
Correspondent Contact CHERYL WARD
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/07/1997
Decision Date 11/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-