BOREALIS AMPLIFIER - 2001232 160 Channel Version
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050006 FDA 510(k)
- FDA Product Code
- DRQ FDA 510(k)
- Models / Variants
- 2001232 160 Channel Version FDA 510(k)2001267 80 Channel Version FDA 510(k)2001268 40 Channel Versio FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2060 FDA 510(k)
- Regulation Number
- 870.2060 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Borealis Amplifier (Clearsign) is an Amplifier and Signal Conditioner, Transducer Signal, designed to amplify and process weak electrical signals from medical transducers. It is classified as a Class II device under FDA regulations and falls under the product code DRQ, adhering to special controls for cardiovascular applications.
This device is intended for use in clinical settings, where it interfaces with transducer signals for diagnostic purposes. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accurate signal amplification. The device holds FDA 510(k) clearance (K050006) and is regulated under the classification for cardiovascular signal processing.
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: Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version ..., Borealis Amplifier (clearsign), Model 2001232 160 Channel Version ..., K050006 FDA 510 (k) - BOREALIS AMPLIFIER (CLEARSIGN), PDF K050006 Borealis Amplifier (Clearsign), Model 2001232 160 Channel ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050006 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K050006 24 fields · synced Sep 19, 2026