FDA 510(k)

SYSMEX NE-8000

K-Number: K883997 · 1988-12-05

ApplicantToa Medical Electronics USA, Inc.

Decision Date1988-12-05

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SYSMEX NE-8000 is the device name listed in this FDA 510(k) record. The listed applicant is Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1988-12-05 under 510(k) number K883997. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX NE-8000?

SYSMEX NE-8000 is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K883997.

When did SYSMEX NE-8000 receive FDA 510(k) clearance?

SYSMEX NE-8000 received FDA 510(k) clearance on 1988-12-05, under 510(k) number K883997.

Who is the listed applicant for SYSMEX NE-8000?

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

What is the FDA product code for SYSMEX NE-8000?

The FDA product code for SYSMEX NE-8000 is GKZ.

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Other records listing Toa Medical Electronics USA, Inc. as applicant

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Related Devices (Code: GKZ)

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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.