FDA 510(k)

WIS1000

K-Number: K112621 · 2012-05-30

ApplicantForeseeson Custom Displays, Inc.

Decision Date2012-05-30

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

WIS1000 is the device name listed in this FDA 510(k) record. The listed applicant is Foreseeson Custom Displays, Inc.. It received FDA 510(k) clearance on 2012-05-30 under 510(k) number K112621. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIS1000?

WIS1000 is a medical device that received FDA 510(k) clearance on 2012-05-30. The listed applicant is Foreseeson Custom Displays, Inc.. The 510(k) number is K112621.

When did WIS1000 receive FDA 510(k) clearance?

WIS1000 received FDA 510(k) clearance on 2012-05-30, under 510(k) number K112621.

Who is the listed applicant for WIS1000?

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

What is the FDA product code for WIS1000?

The FDA product code for WIS1000 is GCJ.

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.