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, Reprocessed
510(k) Number K201699
Device Name Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
Applicant
Surgical Instrument and Savings Inc (Dba Medline Renewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Applicant Contact Stephanie Boyle Mays
Correspondent
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Stephanie Boyle Mays
Regulation Number870.2700
Classification Product Code
NLF  
Date Received06/22/2020
Decision Date 07/22/2020
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
-
-