Reprocessed Blood Pressure Cuff

NPP · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1120

Classification

FDA Product Code: NPP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1120
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown