FDA product code PFY
Low Patient Acuity Monitoring System
Cardiovascular·Class 2·21 CFR 870.2300
US regulatory classifications
- US Product Code (FDA)
- PFYView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 870.2300View CFR Regulation →
- Medical specialty
- Cardiovascular
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.
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About this record
Low Patient Acuity Monitoring System 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.