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FDA 510(k)

EAGLE EYES

K-Number: K964366 · 1997-01-29

ApplicantMech-Tronic Precision Mfg., Ltd.
Decision Date1997-01-29
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EAGLE EYES is the device name listed in this FDA 510(k) record. The listed applicant is Mech-Tronic Precision Mfg., Ltd.. It received FDA 510(k) clearance on 1997-01-29 under 510(k) number K964366. 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 EAGLE EYES?

EAGLE EYES is a medical device that received FDA 510(k) clearance on 1997-01-29. The listed applicant is Mech-Tronic Precision Mfg., Ltd.. The 510(k) number is K964366.

When did EAGLE EYES receive FDA 510(k) clearance?

EAGLE EYES received FDA 510(k) clearance on 1997-01-29, under 510(k) number K964366.

Who is the listed applicant for EAGLE EYES?

The FDA 510(k) record lists Mech-Tronic Precision Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EAGLE EYES?

The FDA product code for EAGLE EYES 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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