FDA 510(k)

NIDEK US-2500 W/BIOMETRY UNIT US-2520

K-Number: K902411 · 1990-10-09

Decision Date1990-10-09

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NIDEK US-2500 W/BIOMETRY UNIT US-2520 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1990-10-09 under 510(k) number K902411. 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 NIDEK US-2500 W/BIOMETRY UNIT US-2520?

NIDEK US-2500 W/BIOMETRY UNIT US-2520 is a medical device that received FDA 510(k) clearance on 1990-10-09. The listed applicant is Nidek, Inc.. The 510(k) number is K902411.

When did NIDEK US-2500 W/BIOMETRY UNIT US-2520 receive FDA 510(k) clearance?

NIDEK US-2500 W/BIOMETRY UNIT US-2520 received FDA 510(k) clearance on 1990-10-09, under 510(k) number K902411.

Who is the listed applicant for NIDEK US-2500 W/BIOMETRY UNIT US-2520?

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

What is the FDA product code for NIDEK US-2500 W/BIOMETRY UNIT US-2520?

The FDA product code for NIDEK US-2500 W/BIOMETRY UNIT US-2520 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.