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 K172625
Device Name Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
Applicant
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Applicant Contact Kim E. Aves
Correspondent
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Correspondent Contact Kim E. Aves
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/01/2017
Decision Date 05/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03030833
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-