OLK

Pulse Oximeter For Over-The-Counter Use

Product code

OLK

Device name

Pulse Oximeter For Over-The-Counter Use

Device class

Class 2

21 CFR

21 CFR 870.2700

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-11-13.

2 summaries are archived here for direct download.