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FDA 510(k)

SUMMIT OPTICS POST-MYDRIATIC SPECTACLES

K-Number: K871800 · 1987-06-11

ApplicantSummit Optics, Inc.
Decision Date1987-06-11
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUMMIT OPTICS POST-MYDRIATIC SPECTACLES is the device name listed in this FDA 510(k) record. The listed applicant is Summit Optics, Inc.. It received FDA 510(k) clearance on 1987-06-11 under 510(k) number K871800. 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 SUMMIT OPTICS POST-MYDRIATIC SPECTACLES?

SUMMIT OPTICS POST-MYDRIATIC SPECTACLES is a medical device that received FDA 510(k) clearance on 1987-06-11. The listed applicant is Summit Optics, Inc.. The 510(k) number is K871800.

When did SUMMIT OPTICS POST-MYDRIATIC SPECTACLES receive FDA 510(k) clearance?

SUMMIT OPTICS POST-MYDRIATIC SPECTACLES received FDA 510(k) clearance on 1987-06-11, under 510(k) number K871800.

Who is the listed applicant for SUMMIT OPTICS POST-MYDRIATIC SPECTACLES?

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

What is the FDA product code for SUMMIT OPTICS POST-MYDRIATIC SPECTACLES?

The FDA product code for SUMMIT OPTICS POST-MYDRIATIC SPECTACLES is HQY.

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Other records listing Summit Optics, 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.

K801822NU-VISION DISP. OPHTHALMIC DRESSING TRAY

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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