Disposable Temperature, Skin and Esophageal Probes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051873 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Disposable Temperature, Skin and Esophageal Probes are medical devices designed for measuring temperature via skin and esophageal routes. They are intended for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.
These probes are supplied as single-use, disposable devices and are indicated for use by qualified medical personnel only. They are provided in configurations such as 12 Fr size, with packaging options including 50 per box, and are compatible with 400 Series temperature probe systems.
Frequently asked questions
What are Disposable Temperature, Skin and Esophageal Probes used for?
Disposable Temperature, Skin and Esophageal Probes are designed for measuring temperature via skin and esophageal routes, intended for use by qualified medical personnel with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes.
How are Disposable Temperature, Skin and Esophageal Probes supplied and configured?
These probes are supplied as single-use, disposable devices in configurations such as 12 Fr size, with packaging options including 50 per box, and are intended for one-time use only.
Are Disposable Temperature, Skin and Esophageal Probes reusable or single-use?
Disposable Temperature, Skin and Esophageal Probes are supplied as single-use, disposable devices and are indicated for use by qualified medical personnel only, meaning they are not intended for reuse after a single application.
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: Temperature | GE HealthCare Service Shop USA, General Purpose Temp Probe, 12 Fr, Disposable, 400-s, 50/Box, DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES by GE HEALTHCARE ..., GE Healthcare > Marquette Temperature Probes and Adapter Cables, Disposable Temperature Probes - Cables and Sensors
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051873 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K051873 24 fields · synced Sep 27, 2026