• 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 Cerebral Oximeter
510(k) Number K182242
Device Name VO200 – NeurOs Cerebral Oximetry System
Applicant
Mespere LifeSciences Inc.
180 Frobisher Drive, Suite 1C
Waterloo,  CA N2V 2A2
Applicant Contact Rebecca S. Li
Correspondent
Mespere LifeSciences Inc.
180 Frobisher Drive, Suite 1C
Waterloo,  CA N2V 2A2
Correspondent Contact Rebecca S. Li
Regulation Number870.2700
Classification Product Code
QEM  
Date Received08/20/2018
Decision Date 12/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-