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Analyzer, Nitrogen Dioxide, Exempt

Analyzer, Nitrogen Dioxide, Exempt is a medical device type in the Anesthesiology 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. This device type includes life-sustaining products.

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
Analyzer, Nitrogen Dioxide, Exempt
Anesthesiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PUG

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Class 2

21 CFR 868.2385

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Anesthesiology

Device Characteristics

No

No

Yes

Not Eligible

Definition

This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 868.9 and the specific limitations of exemption as stated in the ย“Physical Stateย” field of this product code description.