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FDA 510(k)

GLARE WARE

K-Number: K970816 · 1997-06-05

ApplicantErgovision, Inc.
Decision Date1997-06-05
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GLARE WARE is the device name listed in this FDA 510(k) record. The listed applicant is Ergovision, Inc.. It received FDA 510(k) clearance on 1997-06-05 under 510(k) number K970816. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLARE WARE?

GLARE WARE is a medical device that received FDA 510(k) clearance on 1997-06-05. The listed applicant is Ergovision, Inc.. The 510(k) number is K970816.

When did GLARE WARE receive FDA 510(k) clearance?

GLARE WARE received FDA 510(k) clearance on 1997-06-05, under 510(k) number K970816.

Who is the listed applicant for GLARE WARE?

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

What is the FDA product code for GLARE WARE?

The FDA product code for GLARE WARE is HQY.

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Related Devices (Code: HQY)

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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