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FDA 510(k)

THE 3500

K-Number: K822396 · 1982-09-24

ApplicantTracor Northern, Inc.
Decision Date1982-09-24
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE 3500 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 1982-09-24 under 510(k) number K822396. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE 3500?

THE 3500 is a medical device that received FDA 510(k) clearance on 1982-09-24. The listed applicant is Tracor Northern, Inc.. The 510(k) number is K822396.

When did THE 3500 receive FDA 510(k) clearance?

THE 3500 received FDA 510(k) clearance on 1982-09-24, under 510(k) number K822396.

Who is the listed applicant for THE 3500?

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 THE 3500?

The FDA product code for THE 3500 is GWF.

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: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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