PQX — Epinephrine Syringe Class II
FDA product code PQX covers "Epinephrine Syringe", a Class II medical device regulated under 21 CFR 880.5860. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PQX
- Device Class
- Class II
- Regulation Number
- 880.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Intended for intramuscular or subcutaneous injection of epinephrine.