R&D Batteries Part Nos. 5096, 5115, 5128 And 5131
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K951404 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 R&D Batteries Part Nos. 5096, 5115, 5128 and 5131 are electronic clinical thermometers. These devices are classified as continuous measurement thermometers used for monitoring patient temperature.
This device is identified under product code FLL and has received FDA 510(k) clearance under number K951404. It is categorized as a Class II medical device within the General Hospital specialty.
Frequently asked questions
What is the intended use of the R&D Batteries 5096, 5115, 5128, and 5131?
These devices are electronic clinical thermometers specifically designed for the continuous measurement and monitoring of patient body temperature within a clinical setting.
What is the regulatory status of these thermometers?
These devices have received FDA 510(k) clearance under number K951404. They are classified as Class II medical devices within the General Hospital specialty and are identified under product code FLL.
Which specific models are included in this product line?
This product line includes four distinct part numbers: 5096, 5115, 5128, and 5131. All four models function as electronic clinical thermometers for continuous temperature monitoring.
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: K951404 - R&D BATTERIES PART NOS. 5096 | FDA 510 (k), R&D Batteries Part Nos. 5096, 5115, 5128 and 5131, PDF K951404 R&D Batteries Part Nos. 5096, 5115, 5128 And, R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951404 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R & D Batteries, Inc.
Sources (1)
- FDA 510(k) K951404 24 fields · synced Sep 27, 2026