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FDA 510(k)

HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM

K-Number: K863783 · 1987-03-03

Decision Date1987-03-03
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM is the device name listed in this FDA 510(k) record. The listed applicant is Hzi Research Center. It received FDA 510(k) clearance on 1987-03-03 under 510(k) number K863783. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM?

HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM is a medical device that received FDA 510(k) clearance on 1987-03-03. The listed applicant is Hzi Research Center. The 510(k) number is K863783.

When did HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM receive FDA 510(k) clearance?

HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM received FDA 510(k) clearance on 1987-03-03, under 510(k) number K863783.

Who is the listed applicant for HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM?

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

What is the FDA product code for HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM?

The FDA product code for HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM is OLT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: OLT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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