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OLK — Pulse Oximeter For Over-The-Counter Use Class II

FDA Device Classification

Classification Details

Product Code
OLK
Device Class
Class II
Regulation Number
870.2700
Submission Type
Review Panel
AN
Medical Specialty
Cardiovascular
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K211498nonin medicalNonin OTC Pulse Oximeter Model 3250November 13, 2024
K214115masimo corporationMightySat -OTCJanuary 31, 2024