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 Oximeter
510(k) Number K033349
Device Name AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
Applicant
Masimo Corp.
2852 Kelvin Ave.
Irvine,  CA  92614 -5826
Applicant Contact JAMES J CRONIN
Correspondent
Masimo Corp.
2852 Kelvin Ave.
Irvine,  CA  92614 -5826
Correspondent Contact JAMES J CRONIN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received10/20/2003
Decision Date 01/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-