Product code SDJ

Device name
Adjunctive Cardiac Amyloidosis Status Indicator
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.2200
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset