Microstream External Battery Charger
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002163 FDA 510(k)
- FDA Product Code
- CCK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1400 FDA 510(k)
- Regulation Number
- 868.1400 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Microstream External Battery Charger is a device designed to provide power to compatible medical equipment. It serves as an external power source for devices that utilize Microstream technology.
This device is supplied by Oridion Medical 1987 Ltd. and has received FDA 510(k) clearance with product code CCK. It is intended for use in medical settings where battery-powered equipment is utilized, though specific regulatory status beyond FDA clearance is not detailed in the provided information.
Frequently asked questions
What is the Microstream External Battery Charger used for?
The Microstream External Battery Charger is designed to provide power to compatible medical equipment that utilizes Microstream technology. It serves as an external power source for such devices in medical settings where battery-powered equipment is used.
Who manufactures the Microstream External Battery Charger and how is it supplied?
The Microstream External Battery Charger is manufactured by Oridion Medical 1987 Ltd. and is supplied directly by this company. The device originates from their facility in Jerusalem, Israel, as indicated in the authorization records.
What regulatory clearance does the Microstream External Battery Charger have?
The Microstream External Battery Charger has received FDA 510(k) clearance, as stated in the device data. It was found substantially equivalent to a predicate device, with clearance granted under product code CCK and k-number K002163 following a traditional review process.
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: MICROSTREAM EXTERNAL BATTERY CHARGER (K002163) — FDA 510 (k) | Innolitics, PDF K002163 - Microstream External Battery Charger, MICROSTREAM EXTERNAL BATTERY CHARGER 510(k) K002163 - FDA.report, Oridion Medical 1987 , Ltd. FDA 510(k) Products (2001-2020), fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002163 | Class II | Active |
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Manufacturer
- Manufacturer
- Oridion Medical 1987 Ltd.
- FDA Applicant
- Oridion Medical 1987 , Ltd.
Sources (1)
- FDA 510(k) K002163 24 fields · synced Oct 6, 2026