R&D Batteries Part Nos. 5164, 5252, 5634 and 5650
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K951403 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)
This device is a battery system identified by part numbers 5164, 5252, 5634, and 5650, manufactured by R & D Batteries, Inc. It is classified under product code FLL and was determined to be substantially equivalent through a traditional 510(k) clearance process.
The device received FDA 510(k) clearance under K951403 on August 18, 1995, following submission on March 28, 1995. It is authorized for marketing in the United States and is associated with the General Hospital advisory committee (HO). No further details regarding sterility, usage, sizes, storage, or MRI safety are provided in the data.
Frequently asked questions
What is the R&D Batteries Part Nos. 5164, 5252, 5634, and 5650 device used for?
The device is a battery system identified by part numbers 5164, 5252, 5634, and 5650, manufactured by R & D Batteries, Inc. The provided data does not specify clinical indications or intended use, as no functional description beyond its classification as a battery system is included.
How is the R&D Batteries Part Nos. 5164, 5252, 5634, and 5650 supplied or packaged?
The device data does not include information about packaging, supply format, or whether the batteries are supplied individually, in kits, or with accessories. Only the part numbers and manufacturer details are provided.
Is the R&D Batteries Part Nos. 5164, 5252, 5634, and 5650 sterile or single-use?
The data does not mention sterility, single-use status, or reusability for this battery system. Since no such details are provided, it cannot be confirmed whether the device is sterile, intended for single use, or designed for reuse.
What sizes or models are available for the R&D Batteries Part Nos. 5164, 5252, 5634, and 5650?
The device is defined by four specific part numbers: 5164, 5252, 5634, and 5650. These represent the distinct models or references within this battery system line, as no further size variations, capacities, or physical dimensions are specified in the data.
What are the storage requirements for the R&D Batteries Part Nos. 5164, 5252, 5634, and 5650?
No storage conditions, temperature limits, humidity guidelines, or shelf life information are provided in the device data. Therefore, specific storage requirements for this battery system cannot be determined from the available information.
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: R&D Batteries Part Nos. 5164, 5252, 5634 and 5650, R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260… - FDA.report, K951400 - R&D BATTERIES PART NOS. 5064 | FDA 510 (k), R AND D BATTERY REPLACEMENT - fda.report, R&D Batteries 5252 Battery - MedicalBatteryPros.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951403 | Class II | Active |
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Manufacturer
- Manufacturer
- R & D Batteries, Inc.
Sources (1)
- FDA 510(k) K951403 24 fields · synced Sep 27, 2026