Antimicrobial Blood Pressure Cuff

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

Classification

FDA Product Code: OED
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

Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 8

Source

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