PXE — Pressure Monitoring (Air/Gas) Kit Class I
FDA product code PXE covers "Pressure Monitoring (Air/Gas) Kit", a Class I medical device regulated under 21 CFR 868.2610. Submissions are reviewed by the Anesthesiology panel.
Classification Details
- Product Code
- PXE
- Device Class
- Class I
- Regulation Number
- 868.2610
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.