Photoplethysmograph Analysis Software For Over-The-Counter Use

QDB · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2790

Classification

FDA Product Code: QDB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.2790
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 3

Source

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