Identifiers
- 510(k) Number
- K903081 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neos 02 B Pulse Generator is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to provide electrical stimulation to regulate abnormal heart rhythms. It delivers timed electrical impulses to the heart muscle, ensuring proper cardiac pacing in patients with bradycardia or other conduction disorders.
This device is intended for implantable use within the human body and is classified under FDA regulation number 870.3610. Supplied sterile and intended for single-use, it is approved for cardiovascular applications and requires proper surgical implantation by trained medical professionals. The device’s specifications align with traditional 510(k) clearance through the FDA’s Cardiovascular Advisory Committee.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903081 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, GmbH & Co.
Sources (1)
- FDA 510(k) K903081 24 fields · synced Sep 18, 2026