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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device adjunctive cardiac amyloidosis status indicator
Regulation Description Adjunctive cardiovascular status indicator.
Definition The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Product CodeSDJ
Regulation Number 870.2200
Device Class 2


Premarket Reviews
ManufacturerDecision
EKO.AI PTE LTD. D/B/A US2.AI
  SUBSTANTIALLY EQUIVALENT 1
INVISION MEDICAL TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTROMICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1

-
-