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FDA 510(k)

ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM

K-Number: K011320 · 2001-08-09

ApplicantHitachi Medical Systems America, Inc.
Decision Date2001-08-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2001-08-09 under 510(k) number K011320. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM?

ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-09. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K011320.

When did ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM receive FDA 510(k) clearance?

ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM received FDA 510(k) clearance on 2001-08-09, under 510(k) number K011320.

Who is the listed applicant for ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM?

The FDA product code for ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM is DQA.

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Related Devices (Code: DQA)

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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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