FDA product code PXH: Thermometer Kit
PXH is the FDA product code for thermometer kit. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel. Devices under PXH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Thermometer Kit |
| Device class | Class II |
| Regulation | 21 CFR 880.2910 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PXH devices
openFDA lists no recalls for product code PXH.
Frequently asked questions
What is FDA product code PXH?
PXH is the FDA product code for thermometer kit. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel.
What device class is PXH?
Class II, regulation 21 CFR 880.2910. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PXH
- Run a recall and safety report across every PXH manufacturer
- Watch product code PXH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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