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FDA 510(k)

BINOCULAR INDIRECT OPHTHALMOSCOPE

K-Number: K843304 · 1984-11-21

ApplicantMentor O & O, Inc.
Decision Date1984-11-21
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BINOCULAR INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1984-11-21 under 510(k) number K843304. 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 BINOCULAR INDIRECT OPHTHALMOSCOPE?

BINOCULAR INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1984-11-21. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K843304.

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

BINOCULAR INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1984-11-21, under 510(k) number K843304.

Who is the listed applicant for BINOCULAR INDIRECT OPHTHALMOSCOPE?

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

What is the FDA product code for BINOCULAR INDIRECT OPHTHALMOSCOPE?

The FDA product code for BINOCULAR INDIRECT OPHTHALMOSCOPE is HLI.

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Other records listing Mentor O & O, 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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