R&D Batteries # 5615, 5234, 5097
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K935988 FDA 510(k)
- FDA Product Code
- HLI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The R&D Batteries # 5615, 5234, 5097 is an ophthalmoscope battery, which is a device used to power ophthalmoscopes. As an AC-powered or battery-powered ophthalmoscope or hand-held ophthalmoscope replacement battery, it falls under the ophthalmic medical specialty. The device is classified under the product code HLI.
The R&D Batteries # 5615, 5234, 5097 is supplied with the model numbers # 5615, 5234, 5097. The device has been authorized with an FDA 510(k) clearance. The storage and handling of the device should follow standard procedures for medical batteries. The device is used in ophthalmic settings and is subject to the limitations in § 886.9.
Frequently asked questions
What is the R&D Batteries # 5615, 5234, 5097 used for?
The R&D Batteries # 5615, 5234, 5097 is used to power ophthalmoscopes in ophthalmic settings.
How is the device supplied?
The device is supplied with the model numbers # 5615, 5234, 5097.
What is the regulatory status of the R&D Batteries # 5615, 5234, 5097?
The device has been authorized with an FDA 510(k) clearance, classified under the product code HLI.
How should the device be stored and handled?
The storage and handling of the device should follow standard procedures for medical batteries.
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 # 5615, 5234, 5097 (K935988) — FDA 510(k) | Innolitics, PDF K935988 R&D BATTERIES # 5615, 5234, 5097 - 510kdatabase.net, R&D Batteries 5615 Battery - MedicalBatteryPros.com, 5097 - R AND D - MED-72200 - batterytex.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K935988 | Class II | Active |
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Manufacturer
- Manufacturer
- R & D Batteries, Inc.
Sources (1)
- FDA 510(k) K935988 24 fields · synced Sep 24, 2026