Product code NPP

Device name

Reprocessed Blood Pressure Cuff

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1120

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement.

Source

FDA openFDA device classification dataset