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FDA 510(k)

ENGPLUS

K-Number: K010059 · 2001-02-27

ApplicantWestern Systems Research, Inc.
Decision Date2001-02-27
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ENGPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Western Systems Research, Inc.. It received FDA 510(k) clearance on 2001-02-27 under 510(k) number K010059. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGPLUS?

ENGPLUS is a medical device that received FDA 510(k) clearance on 2001-02-27. The listed applicant is Western Systems Research, Inc.. The 510(k) number is K010059.

When did ENGPLUS receive FDA 510(k) clearance?

ENGPLUS received FDA 510(k) clearance on 2001-02-27, under 510(k) number K010059.

Who is the listed applicant for ENGPLUS?

The FDA 510(k) record lists Western Systems Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENGPLUS?

The FDA product code for ENGPLUS is GWN.

Related Clinical Trials

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Other records listing Western Systems Research, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K871466VESTIBULAR AUTOROTATION TEST

Related Devices (Code: GWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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