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 Ventilator, Continuous, Facility Use
510(k) Number K902405
Device Name MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
Applicant
Mallinckrodt Medical
17972 Sky Park Cir., Suite A
Irvine,  CA  92714
Applicant Contact BOB PEARSON
Correspondent
Mallinckrodt Medical
17972 Sky Park Cir., Suite A
Irvine,  CA  92714
Correspondent Contact BOB PEARSON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/31/1990
Decision Date 03/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-