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FDA 510(k)

Aegis Transit System

K-Number: K170757 · 2017-07-14

ApplicantBoston-Biomedical Associates
Decision Date2017-07-14
Product CodeEWY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Aegis Transit System is a medical device manufactured by Boston-Biomedical Associates. It received FDA 510(k) clearance on 2017-07-14 under approval number K170757. The device is classified under product code EWY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aegis Transit System?

Aegis Transit System is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Boston-Biomedical Associates. The 510(k) number is K170757.

When was Aegis Transit System approved by the FDA?

Aegis Transit System received FDA 510(k) clearance on 2017-07-14, under approval number K170757.

What company makes Aegis Transit System?

Aegis Transit System is manufactured by Boston-Biomedical Associates.

What is the FDA product code for Aegis Transit System?

The FDA product code for Aegis Transit System is EWY.

Related Clinical Trials

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Related Devices (Code: EWY)

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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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