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FDA 510(k)

NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE

K-Number: K843597 · 1985-02-15

ApplicantNidek, Inc.
Decision Date1985-02-15
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1985-02-15 under 510(k) number K843597. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE?

NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1985-02-15. The listed applicant is Nidek, Inc.. The 510(k) number is K843597.

When did NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1985-02-15, under 510(k) number K843597.

Who is the listed applicant for NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE?

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

What is the FDA product code for NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE?

The FDA product code for NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE is HLI.

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Other records listing Nidek, Inc. as applicant

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Related Devices (Code: HLI)

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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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