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FDA 510(k)

VersiHD with GuideMe software

K-Number: K230632 · 2023-08-11

ApplicantNxstage Medical, Inc.
Decision Date2023-08-11
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VersiHD with GuideMe software is a medical device manufactured by Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2023-08-11 under approval number K230632. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersiHD with GuideMe software?

VersiHD with GuideMe software is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Nxstage Medical, Inc.. The 510(k) number is K230632.

When was VersiHD with GuideMe software approved by the FDA?

VersiHD with GuideMe software received FDA 510(k) clearance on 2023-08-11, under approval number K230632.

What company makes VersiHD with GuideMe software?

VersiHD with GuideMe software is manufactured by Nxstage Medical, Inc..

What is the FDA product code for VersiHD with GuideMe software?

The FDA product code for VersiHD with GuideMe software is KDI.

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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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