High Speed Magnetic Stimulator
FDA 510(k) K905059 · Cadwell Laboratories, Inc.
510(k) numberK905059
Submission
- Device name
- High Speed Magnetic Stimulator
- Applicant
- Cadwell Laboratories, Inc.
Kennewick, WA, US - Received
- November 8, 1990
- Decision date
- September 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K962458 | Cadwell Four-/Eight-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962457 | Two-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962455 | Four-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
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Questions and answers
When was High Speed Magnetic Stimulator cleared by the FDA?
High Speed Magnetic Stimulator (K905059) received a 510(k) decision of Substantially Equivalent on September 18, 1991, 314 days after the submission was received.
What is the product code of K905059?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.