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FDA 510(k)

SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG

K-Number: K900482 · 1990-06-20

ApplicantAxon Systems, Inc.
Decision Date1990-06-20
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG is the device name listed in this FDA 510(k) record. The listed applicant is Axon Systems, Inc.. It received FDA 510(k) clearance on 1990-06-20 under 510(k) number K900482. 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 SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG?

SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Axon Systems, Inc.. The 510(k) number is K900482.

When did SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG receive FDA 510(k) clearance?

SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG received FDA 510(k) clearance on 1990-06-20, under 510(k) number K900482.

Who is the listed applicant for SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG?

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

What is the FDA product code for SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG?

The FDA product code for SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG is GWF.

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Other records listing Axon Systems, Inc. as applicant

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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.

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Official Source

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