Product code OLK

Device name

Pulse Oximeter For Over-The-Counter Use

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.2700

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset