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FDA 510(k)

OCULAR-BIOMETER 4000

K-Number: K820042 · 1982-07-22

ApplicantRadionics, Inc.
Decision Date1982-07-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OCULAR-BIOMETER 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1982-07-22 under 510(k) number K820042. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULAR-BIOMETER 4000?

OCULAR-BIOMETER 4000 is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Radionics, Inc.. The 510(k) number is K820042.

When did OCULAR-BIOMETER 4000 receive FDA 510(k) clearance?

OCULAR-BIOMETER 4000 received FDA 510(k) clearance on 1982-07-22, under 510(k) number K820042.

Who is the listed applicant for OCULAR-BIOMETER 4000?

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

What is the FDA product code for OCULAR-BIOMETER 4000?

The FDA product code for OCULAR-BIOMETER 4000 is IYO.

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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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