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FDA 510(k)

IS3

K-Number: K180527 · 2018-05-16

ApplicantHiossen, Inc.
Decision Date2018-05-16
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IS3 is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2018-05-16 under approval number K180527. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IS3?

IS3 is a medical device that received FDA 510(k) clearance on 2018-05-16. It is manufactured by Hiossen, Inc.. The 510(k) number is K180527.

When was IS3 approved by the FDA?

IS3 received FDA 510(k) clearance on 2018-05-16, under approval number K180527.

What company makes IS3?

IS3 is manufactured by Hiossen, Inc..

What is the FDA product code for IS3?

The FDA product code for IS3 is EKX.

Other Devices by Hiossen, Inc.

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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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