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 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K031741
Device Name MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
Applicant
Alaris Medical Systems, Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Applicant Contact RENEE L FLUET
Correspondent
Alaris Medical Systems, Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Correspondent Contact RENEE L FLUET
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/04/2003
Decision Date 02/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-