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VersiHD with GuideMe software — Nxstage Medical, Inc. (510(k) K230632)

VersiHD with GuideMe software — Nxstage Medical, Inc. (510(k) K230632) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: VersiHD with GuideMe software; Applicant: Nxstage Medical, Inc.; Clearance track: 510(k).

Device nameVersiHD with GuideMe software
ApplicantNxstage Medical, Inc.
Clearance track510(k)
Submission numberK230632
DecisionSubstantially Equivalent
Decision date2023-08-11
Date received2023-03-07
Product codeKDI
Device class2
Medical specialtyGastroenterology, Urology
Applicant locationMA, US
SourceopenFDA device

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