FDA Product Code OLK: Pulse Oximeter For Over-the-counter Use
Non-wearable, Fingertip Pulse Oximeter Intended For Over-the-counter Use For Non-continuous Monitoring
Leading manufacturers include Nonin Medical, Inc. and Masimo Corporation.
2
Total
2
Cleared
1021d
Avg days
2024
Since
List of Pulse Oximeter For Over-the-counter Use devices cleared through 510(k)
2 devices
Cleared
Nov 13, 2024
Nonin OTC Pulse Oximeter Model 3250
Nonin Medical, Inc.
Anesthesiology
1279d
Cleared
Jan 31, 2024
MightySat -OTC
Masimo Corporation
Anesthesiology
762d
How to use this database
This page lists all FDA 510(k) submissions for Pulse Oximeter For Over-the-counter Use devices (product code OLK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →