Product code PPW

Device name

Adjunctive Cardiovascular 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 cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). 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