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Pulse Oximeter For Over-The-Counter Use

Pulse Oximeter For Over-The-Counter Use is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Pulse Oximeter For Over-The-Counter Use
Cardiovascular Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OLK

View Product Code Classification

Class 2

21 CFR 870.2700

View CFR Regulation

Cardiovascular

Device Characteristics

No

No

No

Not Eligible

Definition

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

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