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FDA 510(k)

THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE

K-Number: K854244 · 1985-11-12

ApplicantKeeler Instruments, Inc.
Decision Date1985-11-12
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K854244. 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 THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE?

THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K854244.

When did THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854244.

Who is the listed applicant for THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE?

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

What is the FDA product code for THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE?

The FDA product code for THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE is HLI.

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Other records listing Keeler Instruments, 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.

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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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