Electronic Digital Fever Thermometer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833755 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K811634 Active Cleared 30 Jun 1981

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• Norelco Electronic Digital Thermometer

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  FDA 510(k) K811672 Active Cleared 26 Jun 1981

See all devices from North American Philips Corp. →

• What types of settings is this thermometer approved for use in, and how does that affect its intended use?

  This electronic digital fever thermometer is cleared for use in general hospital settings, as indicated by its classification under the General Hospital (HO) advisory committee during its FDA review. This means it is designed to support clinical assessments in hospitals, but its approval does not extend to home use or other non-hospital environments unless explicitly stated elsewhere. The clearance is based on its role as a temperature measurement instrument for detecting fever, so it is not intended for diagnostic purposes beyond temperature monitoring.

• Is this thermometer meant for single-use or reusable applications, and how should I determine which variant I need?

  This device is intended for either single-use or reusable applications, depending on the specific model variant. The regulatory data does not specify which models fall into each category, so you would need to consult the manufacturer’s documentation or product labeling to confirm compatibility with your facility’s infection control policies. Reusable models would require cleaning and sterilization between uses, while single-use models would be discarded after one use.

• What should I know about the storage of this thermometer before use?

  The regulatory data does not provide explicit storage conditions for this thermometer, such as temperature ranges or environmental requirements. However, as an electronic device, it should ideally be stored in a clean, dry place away from extreme temperatures or moisture to prevent damage. If the thermometer is reusable, ensure it is stored in a manner that maintains its sterility until use, following manufacturer guidelines. For single-use models, check the packaging for any storage instructions.

• How do I know if this thermometer is compatible with my facility’s MRI environment?

  The regulatory data explicitly states that this thermometer is not specified as MRI-safe. If your facility requires MRI-compatible devices, you should avoid using this thermometer in or near MRI machines, as there is no information confirming its safety in such environments. Always verify compatibility with your facility’s MRI protocols before use.