DXQ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1120
Classification
FDA Product Code
DXQ
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
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.