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FDA 510(k)

MIZAR, BASIS BE, SANDMAN DIGITAL

K-Number: K003154 · 2001-01-05

ApplicantEb Neuro S.P.A.
Decision Date2001-01-05
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MIZAR, BASIS BE, SANDMAN DIGITAL is the device name listed in this FDA 510(k) record. The listed applicant is Eb Neuro S.P.A.. It received FDA 510(k) clearance on 2001-01-05 under 510(k) number K003154. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIZAR, BASIS BE, SANDMAN DIGITAL?

MIZAR, BASIS BE, SANDMAN DIGITAL is a medical device that received FDA 510(k) clearance on 2001-01-05. The listed applicant is Eb Neuro S.P.A.. The 510(k) number is K003154.

When did MIZAR, BASIS BE, SANDMAN DIGITAL receive FDA 510(k) clearance?

MIZAR, BASIS BE, SANDMAN DIGITAL received FDA 510(k) clearance on 2001-01-05, under 510(k) number K003154.

Who is the listed applicant for MIZAR, BASIS BE, SANDMAN DIGITAL?

The FDA 510(k) record lists Eb Neuro S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIZAR, BASIS BE, SANDMAN DIGITAL?

The FDA product code for MIZAR, BASIS BE, SANDMAN DIGITAL is GWL.

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Other records listing Eb Neuro S.P.A. as applicant

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.

K242832NExT Station; NExT Station AdvancedK242305BE Plus PRO, Neurotravel LIGHTK121996BE PLUS LTM AMPLIFIER GWI AMPLIFIERK093728BE MICRO, TREAK073415NEMUS SYSTEM; NEMUS PC PERIPHERALK061996SANDMAN POCKET

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Related Devices (Code: GWL)

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.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

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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