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FDA 510(k)

ZENITH

K-Number: K833145 · 1983-11-28

ApplicantJeneric Ind.
Decision Date1983-11-28
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENITH is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric Ind.. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K833145. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENITH?

ZENITH is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Jeneric Ind.. The 510(k) number is K833145.

When did ZENITH receive FDA 510(k) clearance?

ZENITH received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833145.

Who is the listed applicant for ZENITH?

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

What is the FDA product code for ZENITH?

The FDA product code for ZENITH is EJH.

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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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