FDA 510(k)

TELEFACTOR D/EEG-32

K-Number: K925838 · 1993-04-30

Decision Date1993-04-30

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TELEFACTOR D/EEG-32 is the device name listed in this FDA 510(k) record. The listed applicant is Grass-Telefactor Product Group. It received FDA 510(k) clearance on 1993-04-30 under 510(k) number K925838. 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 TELEFACTOR D/EEG-32?

TELEFACTOR D/EEG-32 is a medical device that received FDA 510(k) clearance on 1993-04-30. The listed applicant is Grass-Telefactor Product Group. The 510(k) number is K925838.

When did TELEFACTOR D/EEG-32 receive FDA 510(k) clearance?

TELEFACTOR D/EEG-32 received FDA 510(k) clearance on 1993-04-30, under 510(k) number K925838.

Who is the listed applicant for TELEFACTOR D/EEG-32?

The FDA 510(k) record lists Grass-Telefactor Product Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELEFACTOR D/EEG-32?

The FDA product code for TELEFACTOR D/EEG-32 is GWQ.

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Other records listing Grass-Telefactor Product Group as applicant

K992291H20- TETHERED OPTION K974583DEEGLITE K974587H2O K972202DEEG-LITE K884937BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING K870432A1-A2 AMBULATORY EEG CASSETTE RECORDER

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Related Devices (Code: GWQ)

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 Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.