Identifiers
- 510(k) Number
- K970686 FDA 510(k)
- FDA Product Code
- FMT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5130 FDA 510(k)
- Regulation Number
- 880.5130 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accutemp-Probe is a temperature probe designed to obtain accurate readings of a patient’s skin temperature. It is a low‑profile instrument that can be securely positioned to optimize heat conduction from the skin to the sensor, and it is compatible with GE Healthcare/Ohmeda incubators for infant radiant warming applications.
The probe is supplied as a single‑use, disposable device to reduce the risk of cross‑contamination. It was cleared by the FDA through a traditional 510(k) submission (decision date 1997‑08‑25, decision description Substantially Equivalent) and is classified as a Class II device (product code FMT). No specific MRI safety or size information is provided in the source data.
Frequently asked questions
What is the Accutemp-Probe used for?
This device is designed to obtain accurate readings of a patient's skin temperature. It is specifically compatible with GE Healthcare/Ohmeda incubators for infant radiant warming applications.
Is the Accutemp-Probe a single-use or reusable device?
The probe is supplied as a single-use, disposable device. This design is intended to reduce the risk of cross-contamination between patients.
How is the probe positioned for use?
It is a low-profile instrument that can be securely positioned to optimize heat conduction from the skin to the sensor, ensuring reliable temperature measurement.
What is the regulatory status of the Accutemp-Probe?
The device was cleared by the FDA through a traditional 510(k) submission, classified as a Class II device with the product code FMT.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ameritus AccuTemp Temperature Probes - Medline, Kentec Medical Thermometers w/Cover AccuTemp Acrylic Temperature Probe ..., Kentec Medical, KENTEC MEDICAL INC Ameritus AccuTemp Temperature Probes 230 10 Each-MDL ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970686 | Class II | Active |
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Manufacturer
- Manufacturer
- Kentec Medical, Inc.
Sources (1)
- FDA 510(k) K970686 24 fields · synced Sep 21, 2026