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FDA 510(k)

WIRELESS EEG RECORDING SYSTEM MODEL W32

K-Number: K963195 · 1997-07-29

ApplicantCme Telemetrix, Inc.
Decision Date1997-07-29
Product CodeGYE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WIRELESS EEG RECORDING SYSTEM MODEL W32 is the device name listed in this FDA 510(k) record. The listed applicant is Cme Telemetrix, Inc.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K963195. The device is classified under product code GYE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIRELESS EEG RECORDING SYSTEM MODEL W32?

WIRELESS EEG RECORDING SYSTEM MODEL W32 is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Cme Telemetrix, Inc.. The 510(k) number is K963195.

When did WIRELESS EEG RECORDING SYSTEM MODEL W32 receive FDA 510(k) clearance?

WIRELESS EEG RECORDING SYSTEM MODEL W32 received FDA 510(k) clearance on 1997-07-29, under 510(k) number K963195.

Who is the listed applicant for WIRELESS EEG RECORDING SYSTEM MODEL W32?

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

What is the FDA product code for WIRELESS EEG RECORDING SYSTEM MODEL W32?

The FDA product code for WIRELESS EEG RECORDING SYSTEM MODEL W32 is GYE.

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Related Devices (Code: GYE)

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.

K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERTelediagnostic Systems, Inc.K895895MODEL 219 TELEMETRY SYSTEMMennen Medical, Inc.K891405BMS-2000 MOBILE EEG SYSTEMBuckman Co., Inc.K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERTelediagnostic Systems, Inc.K883947ISO-100 ISOLATION AMPLIFIERTelediagnostic Systems, Inc.K883461DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIESBiohm, 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.

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