Cadwell 5200
FDA 510(k) K820031 · Cadwell Laboratories, Inc.
510(k) numberK820031
Submission
- Device name
- Cadwell 5200
- Applicant
- Cadwell Laboratories, Inc.
Mchenry, IL, US - Received
- January 6, 1982
- Decision date
- February 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K003508 | Nc-StatJXE · Traditional | Neurometrix, Inc. | 01/17/2001SE |
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| K962458 | Cadwell Four-/Eight-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962457 | Two-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
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Questions and answers
When was Cadwell 5200 cleared by the FDA?
Cadwell 5200 (K820031) received a 510(k) decision of Substantially Equivalent on February 4, 1982, 29 days after the submission was received.
What is the product code of K820031?
The FDA product code is JXE – Device, Nerve Conduction Velocity Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1550.