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FDA 510(k)

OPHTHALMOSCOPE, BINOCULAR, INDIRECT

K-Number: K772214 · 1977-12-13

ApplicantVarian Assoc., Inc.
Decision Date1977-12-13
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMOSCOPE, BINOCULAR, INDIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Varian Assoc., Inc.. It received FDA 510(k) clearance on 1977-12-13 under 510(k) number K772214. 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 OPHTHALMOSCOPE, BINOCULAR, INDIRECT?

OPHTHALMOSCOPE, BINOCULAR, INDIRECT is a medical device that received FDA 510(k) clearance on 1977-12-13. The listed applicant is Varian Assoc., Inc.. The 510(k) number is K772214.

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

OPHTHALMOSCOPE, BINOCULAR, INDIRECT received FDA 510(k) clearance on 1977-12-13, under 510(k) number K772214.

Who is the listed applicant for OPHTHALMOSCOPE, BINOCULAR, INDIRECT?

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

What is the FDA product code for OPHTHALMOSCOPE, BINOCULAR, INDIRECT?

The FDA product code for OPHTHALMOSCOPE, BINOCULAR, INDIRECT 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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