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FDA 510(k)

3D SCOPE

K-Number: K961182 · 1996-07-19

ApplicantOktas
Decision Date1996-07-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3D SCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Oktas. It received FDA 510(k) clearance on 1996-07-19 under 510(k) number K961182. 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 3D SCOPE?

3D SCOPE is a medical device that received FDA 510(k) clearance on 1996-07-19. The listed applicant is Oktas. The 510(k) number is K961182.

When did 3D SCOPE receive FDA 510(k) clearance?

3D SCOPE received FDA 510(k) clearance on 1996-07-19, under 510(k) number K961182.

Who is the listed applicant for 3D SCOPE?

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

What is the FDA product code for 3D SCOPE?

The FDA product code for 3D SCOPE is GCJ.

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Other records listing Oktas as applicant

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.

K9702143 DIMENSIONAL VIDEO ENDOSCOPEK970369VISTA MINI CAMERA SYSTEMK946171VIDEO ENDOSCOPE SYSTEM WITH ZOOMK944254OKTAS STEREO VIEWING SYSTEMK944256OKTAS INTRA-ORAL DENTAL CAMERAK941919OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM

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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

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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