Kilowin

FDA 510(k) K971214 · Cadwell Laboratories, Inc.

Substantially Equivalent

510(k) numberK971214

Submission

Device name
Kilowin
Applicant
Cadwell Laboratories, Inc.
Kennewick, WA, US
Received
April 2, 1997
Decision date
June 11, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GWE – Stimulator, Photic, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1890
Specialty
Neurology

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K962458Cadwell Four-/Eight-Channel PreamplifierGWF · Traditional 01/13/1997SE
K962457Two-Channel PreamplifierGWF · Traditional 01/13/1997SE
K962455Four-Channel PreamplifierGWF · Traditional 01/13/1997SE
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Questions and answers

When was Kilowin cleared by the FDA?

Kilowin (K971214) received a 510(k) decision of Substantially Equivalent on June 11, 1998, 435 days after the submission was received.

What is the product code of K971214?

The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.