FDA 510(k)

NIDEK MODEL VT-4000, MODIFICATION

K-Number: K936302 · 1994-07-15

Decision Date1994-07-15

Product CodeHQE

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

NIDEK MODEL VT-4000, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1994-07-15 under 510(k) number K936302. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK MODEL VT-4000, MODIFICATION?

NIDEK MODEL VT-4000, MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-07-15. The listed applicant is Nidek, Inc.. The 510(k) number is K936302.

When did NIDEK MODEL VT-4000, MODIFICATION receive FDA 510(k) clearance?

NIDEK MODEL VT-4000, MODIFICATION received FDA 510(k) clearance on 1994-07-15, under 510(k) number K936302.

Who is the listed applicant for NIDEK MODEL VT-4000, MODIFICATION?

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 MODEL VT-4000, MODIFICATION?

The FDA product code for NIDEK MODEL VT-4000, MODIFICATION is HQE.

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Other records listing Nidek, Inc. as applicant

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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.