Craftemp Et 3045 Electronic Thermometry System
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K852454 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)
The Craftemp Et 3045 Electronic Thermometry System is a continuous measurement thermometer, classified as a Class II device with special controls. It is designed to provide electronic thermometry. The device is identified by the product code FLL.
The Craftemp Et 3045 Electronic Thermometry System is supplied by Gambro, Inc. It has been cleared by the FDA with the k number K852454, and the decision was made on August 16, 1985. The device is used for electronic thermometry, and its storage and use are subject to the specifications provided by the manufacturer.
Frequently asked questions
What is the Craftemp ET 3045 used for?
The Craftemp ET 3045 Electronic Thermometry System is used for electronic thermometry, providing continuous measurement.
How is the Craftemp ET 3045 supplied?
The device is supplied by Gambro, Inc., and its storage and use are subject to the manufacturer's specifications.
What is the regulatory status of the Craftemp ET 3045?
The device has been cleared by the FDA with the k number K852454, indicating it is substantially equivalent to a predicate device.
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: K852454 - CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY... | FDA 510(k), Craftemp Et 3045 Electronic Thermometry System, CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM… - FDA.report, K852454 - CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY... | FDA 510(k), CRAFTEMP Trademark - Registration Number 1169045 - Serial Number ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K852454 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K852454 24 fields · synced Sep 21, 2026