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R&D Batteries Part Nos. 5041 & 5655

FDA 510(k)

Class II (US FDA 510(k))

510(k) K951399

by R & D Batteries, Inc.

Identifiers

510(k) Number
K951399 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. 5041 & 5655 are disposable primary batteries designed for use in medical devices requiring reliable power sources. These batteries are classified as Class 2 General Hospital devices under FDA product code FLL, intended for integration into powered medical equipment.

These batteries are supplied as single-use, non-rechargeable units and are intended for use in compatible medical devices such as patient monitors, infusion pumps, or other portable medical instrumentation. Cleared through the Traditional 510(k) pathway, they meet FDA requirements for safety and performance as documented in clearance K951399. No specific sterility or MRI safety information is provided in the regulatory data.

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: K951399 - R&D BATTERIES PART NOS. 5041 & 5655 | FDA 510 (k), R&D BATTERIES PART NOS. 5041 & 5655 - Innolitics, PDF K951399 - R&D Batteries Part Nos. 5041 & 5655, R&D BATTERIES PART NOS. 5041 & 5655 510(k) K951399 - FDA.report, R&D Batteries - 5551

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
R & D Batteries, Inc.

Sources (1)

  • FDA 510(k) K951399 24 fields · synced Sep 19, 2026