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FDA 510(k)

MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER

K-Number: K910279 · 1991-09-04

ApplicantNew England Medical Instruments, Inc.
Decision Date1991-09-04
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is New England Medical Instruments, Inc.. It received FDA 510(k) clearance on 1991-09-04 under 510(k) number K910279. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER?

MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER is a medical device that received FDA 510(k) clearance on 1991-09-04. The listed applicant is New England Medical Instruments, Inc.. The 510(k) number is K910279.

When did MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER receive FDA 510(k) clearance?

MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER received FDA 510(k) clearance on 1991-09-04, under 510(k) number K910279.

Who is the listed applicant for MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER?

The FDA 510(k) record lists New England Medical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER?

The FDA product code for MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER is GWQ.

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Other records listing New England Medical Instruments, 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.

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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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