FDA product code PRK

Device Indicating An Exhalation Event

Anesthesiology·Class 2·21 CFR 868.2375
US regulatory classifications
US Product Code (FDA)
PRK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 868.2375
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Medical specialty
Anesthesiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

To provide visual indication of each exhalation event

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About this record

Device Indicating An Exhalation Event 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.

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.