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FDA 510(k)

3DSEE

K-Number: K951646 · 1995-10-04

ApplicantIntl. Telepresence Corp.
Decision Date1995-10-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3DSEE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Telepresence Corp.. It received FDA 510(k) clearance on 1995-10-04 under 510(k) number K951646. 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 3DSEE?

3DSEE is a medical device that received FDA 510(k) clearance on 1995-10-04. The listed applicant is Intl. Telepresence Corp.. The 510(k) number is K951646.

When did 3DSEE receive FDA 510(k) clearance?

3DSEE received FDA 510(k) clearance on 1995-10-04, under 510(k) number K951646.

Who is the listed applicant for 3DSEE?

The FDA 510(k) record lists Intl. Telepresence Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DSEE?

The FDA product code for 3DSEE 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 CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED 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.

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