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 Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
510(k) Number K223622
Device Name FaceHeart Vitals Software Development Kit (FH vitals SDK)
Applicant
Faceheart Corp.
P.O. Box 309, Ugland House
Grand Cayman,  KY KY1-1104
Applicant Contact Morris Chung
Correspondent
Faceheart Corp.
P.O. Box 309, Ugland House
Grand Cayman,  KY KY1-1104
Correspondent Contact Morris Chung
Regulation Number870.2785
Classification Product Code
QME  
Date Received12/05/2022
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-