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FDA 510(k)

KOI BLUE FIELD ENTOPTOSCOPE

K-Number: K812764 · 1981-12-02

ApplicantKoi, Inc.
Decision Date1981-12-02
Product CodeHKL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOI BLUE FIELD ENTOPTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Koi, Inc.. It received FDA 510(k) clearance on 1981-12-02 under 510(k) number K812764. The device is classified under product code HKL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOI BLUE FIELD ENTOPTOSCOPE?

KOI BLUE FIELD ENTOPTOSCOPE is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Koi, Inc.. The 510(k) number is K812764.

When did KOI BLUE FIELD ENTOPTOSCOPE receive FDA 510(k) clearance?

KOI BLUE FIELD ENTOPTOSCOPE received FDA 510(k) clearance on 1981-12-02, under 510(k) number K812764.

Who is the listed applicant for KOI BLUE FIELD ENTOPTOSCOPE?

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

What is the FDA product code for KOI BLUE FIELD ENTOPTOSCOPE?

The FDA product code for KOI BLUE FIELD ENTOPTOSCOPE is HKL.

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Other records listing Koi, 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.

K843247KOI PACHYMETERK830366DIAMOND KNIFEK812450KOI DIAMOND KNIFEK812097KOI LACREMAL HOOK & DILATORK812010KOI LACRIMAL INTUBATION SYSTEMK812011BLADE GAUGE

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Related Devices (Code: HKL)

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.

K001111PANORET, MODEL 1000ACmt Medical Technologies, Ltd.K950789STREAK RETINOSCOPE RX-1Neitz Instruments Company, Ltd.K950790STREAK RETINOSCOPE RX-2Neitz Instruments Company, Ltd.K893171VISTA STREAK RETINOSCOPE (AC-POWERED)Keeler Instruments, Inc.K800238MOIRE FRINGE VISOMETER AFTER LOTMARHagg-Streit Service, Inc.

Official Source

View on FDA Database →

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

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