Product code SDY

Device name

Loss Of Pulse Notification Software

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.2790

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis.

Source

FDA openFDA device classification dataset