• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

  • 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 hardware and software for optical camera-based measurement of heart rate and respiratory rate
De Novo Number DEN200038
Device Name Gili Pro BioSensor (also known as “Gili BioSensor System”)
Requester
ContinUse Biometrics Ltd.
habarzel 32b
tel-aviv,  IL 6971048
Contact sagi polani
Regulation Number870.2786
Classification Product Code
QOK  
Date Received06/12/2020
Decision Date 04/01/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
Type Direct
-
-