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FDA 510(k)

LEMPERT OPTIC DISC ANALYSIS SYSTEM

K-Number: K923708 · 1993-03-19

ApplicantLempert Ophthalmic Instruments
Decision Date1993-03-19
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LEMPERT OPTIC DISC ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lempert Ophthalmic Instruments. It received FDA 510(k) clearance on 1993-03-19 under 510(k) number K923708. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEMPERT OPTIC DISC ANALYSIS SYSTEM?

LEMPERT OPTIC DISC ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1993-03-19. The listed applicant is Lempert Ophthalmic Instruments. The 510(k) number is K923708.

When did LEMPERT OPTIC DISC ANALYSIS SYSTEM receive FDA 510(k) clearance?

LEMPERT OPTIC DISC ANALYSIS SYSTEM received FDA 510(k) clearance on 1993-03-19, under 510(k) number K923708.

Who is the listed applicant for LEMPERT OPTIC DISC ANALYSIS SYSTEM?

The FDA 510(k) record lists Lempert Ophthalmic Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEMPERT OPTIC DISC ANALYSIS SYSTEM?

The FDA product code for LEMPERT OPTIC DISC ANALYSIS SYSTEM is HKI.

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Related Devices (Code: HKI)

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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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