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Pulse Oximeter For Over-The-Counter Use

FDA product code OLK · 2 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2700
Review panel
AN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-01-31 – 2024-11-13

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

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