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FDA 510(k)

Cascade IOMAX Intraoperative Monitor

K-Number: K162199 · 2017-03-02

ApplicantCadwell Industries, Inc.
Decision Date2017-03-02
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cascade IOMAX Intraoperative Monitor is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2017-03-02 under approval number K162199. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cascade IOMAX Intraoperative Monitor?

Cascade IOMAX Intraoperative Monitor is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K162199.

When was Cascade IOMAX Intraoperative Monitor approved by the FDA?

Cascade IOMAX Intraoperative Monitor received FDA 510(k) clearance on 2017-03-02, under approval number K162199.

What company makes Cascade IOMAX Intraoperative Monitor?

Cascade IOMAX Intraoperative Monitor is manufactured by Cadwell Industries, Inc..

What is the FDA product code for Cascade IOMAX Intraoperative Monitor?

The FDA product code for Cascade IOMAX Intraoperative Monitor is GWF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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