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FDA 510(k)

NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE

K-Number: K843596 · 1985-02-15

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

Device Summary

NIDEK-BINOCULAR 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 K843596. 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-BINOCULAR INDIRECT OPHTHALMOSCOPE?

NIDEK-BINOCULAR 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 K843596.

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

NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1985-02-15, under 510(k) number K843596.

Who is the listed applicant for NIDEK-BINOCULAR 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-BINOCULAR INDIRECT OPHTHALMOSCOPE?

The FDA product code for NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE is 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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