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FDA 510(k)

ALCON INDIRECT OPHTHALMOSCOPE

K-Number: K822104 · 1982-08-10

ApplicantAlcon Laboratories
Decision Date1982-08-10
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALCON INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories. It received FDA 510(k) clearance on 1982-08-10 under 510(k) number K822104. 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 ALCON INDIRECT OPHTHALMOSCOPE?

ALCON INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1982-08-10. The listed applicant is Alcon Laboratories. The 510(k) number is K822104.

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

ALCON INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1982-08-10, under 510(k) number K822104.

Who is the listed applicant for ALCON INDIRECT OPHTHALMOSCOPE?

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

What is the FDA product code for ALCON INDIRECT OPHTHALMOSCOPE?

The FDA product code for ALCON 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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