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 K050056
Device Name MODEL 2500A PALMSAT PULSE OXIMETER
Applicant
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Applicant Contact LORI ROTH
Correspondent
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Correspondent Contact LORI ROTH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/11/2005
Decision Date 06/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-