PFY — Low Patient Acuity Monitoring System Class II
FDA product code PFY covers "Low Patient Acuity Monitoring System", a Class II medical device regulated under 21 CFR 870.2300. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- PFY
- Device Class
- Class II
- Regulation Number
- 870.2300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.