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FDA 510(k)

IMAGE VUE EEG

K-Number: K980477 · 1998-08-06

ApplicantSam Technology, Inc.
Decision Date1998-08-06
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IMAGE VUE EEG is the device name listed in this FDA 510(k) record. The listed applicant is Sam Technology, Inc.. It received FDA 510(k) clearance on 1998-08-06 under 510(k) number K980477. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE VUE EEG?

IMAGE VUE EEG is a medical device that received FDA 510(k) clearance on 1998-08-06. The listed applicant is Sam Technology, Inc.. The 510(k) number is K980477.

When did IMAGE VUE EEG receive FDA 510(k) clearance?

IMAGE VUE EEG received FDA 510(k) clearance on 1998-08-06, under 510(k) number K980477.

Who is the listed applicant for IMAGE VUE EEG?

The FDA 510(k) record lists Sam Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGE VUE EEG?

The FDA product code for IMAGE VUE EEG is OLX.

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Related Devices (Code: OLX)

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.

K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND NeuroK252565PreOp v3Clouds of CareK250239NeuroMatchLVIS CorporationK241513SourcererBrain Electrophysiology Laboratory Company, LLCK233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OYK210199RICOH MEGRicoh Company, Ltd.

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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