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FDA 510(k)

PHOTIC STIMULATOR TM-3030-70

K-Number: K842964 · 1984-12-28

ApplicantTracor Northern, Inc.
Decision Date1984-12-28
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PHOTIC STIMULATOR TM-3030-70 is the device name listed in this FDA 510(k) record. The listed applicant is Tracor Northern, Inc.. It received FDA 510(k) clearance on 1984-12-28 under 510(k) number K842964. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTIC STIMULATOR TM-3030-70?

PHOTIC STIMULATOR TM-3030-70 is a medical device that received FDA 510(k) clearance on 1984-12-28. The listed applicant is Tracor Northern, Inc.. The 510(k) number is K842964.

When did PHOTIC STIMULATOR TM-3030-70 receive FDA 510(k) clearance?

PHOTIC STIMULATOR TM-3030-70 received FDA 510(k) clearance on 1984-12-28, under 510(k) number K842964.

Who is the listed applicant for PHOTIC STIMULATOR TM-3030-70?

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

What is the FDA product code for PHOTIC STIMULATOR TM-3030-70?

The FDA product code for PHOTIC STIMULATOR TM-3030-70 is GWE.

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Other records listing Tracor Northern, 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.

K883340NEURAL MAGNETIC STIMULATOR, THE D190K874733GUARDIAN, EEG BRAIN MONITORING SYSTEMK860968TM-3400, NOMAD (MODIFIED)K860903TM-3600 A NEURODIAGNOSTIC SYSTEMK852587CDSA(COLOR DENSITY, SPECTRAL ARRRAY)K850109NOMAD TM-3400

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Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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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