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FDA 510(k)

ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM

K-Number: K022164 · 2002-07-26

ApplicantZeta Development Laboratories
Decision Date2002-07-26
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeta Development Laboratories. It received FDA 510(k) clearance on 2002-07-26 under 510(k) number K022164. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM?

ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-26. The listed applicant is Zeta Development Laboratories. The 510(k) number is K022164.

When did ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM receive FDA 510(k) clearance?

ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM received FDA 510(k) clearance on 2002-07-26, under 510(k) number K022164.

Who is the listed applicant for ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM?

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

What is the FDA product code for ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM?

The FDA product code for ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM is HKI.

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Official Source

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