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 K254169
Device Name SmartSpectra Vital Signs Monitor 1.0
Applicant
Presage Security, Inc. d/b/a Presage Technologies, Inc.
50 Catoctin Cir. NE #101
Office 114
Leesburg,  VA  20176
Applicant Contact Michael Kenney
Correspondent
Presage Security, Inc. d/b/a Presage Technologies, Inc.
50 Catoctin Cir. NE #101
Office 114
Leesburg,  VA  20176
Correspondent Contact Michael Kenney
Regulation Number870.2785
Classification Product Code
QME  
Date Received12/23/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-