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FDA 510(k)

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM

K-Number: K963669 · 1996-12-12

ApplicantAstro-Med, Inc.
Decision Date1996-12-12
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Astro-Med, Inc.. It received FDA 510(k) clearance on 1996-12-12 under 510(k) number K963669. 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 GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM?

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-12. The listed applicant is Astro-Med, Inc.. The 510(k) number is K963669.

When did GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM receive FDA 510(k) clearance?

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM received FDA 510(k) clearance on 1996-12-12, under 510(k) number K963669.

Who is the listed applicant for GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM?

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

What is the FDA product code for GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM?

The FDA product code for GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM is GWL.

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Other records listing Astro-Med, Inc. 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.

K081551TWIN NEUROTRAC-IIIK050425AURA-PSGK033978ADAMK970951GRASS BRAINWAVE SOFTWAREK934644K3 SYSTEMK912929DASH IV

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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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