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FDA 510(k)

3 DIMENSIONAL VIDEO ENDOSCOPE

K-Number: K970214 · 1997-04-14

ApplicantOktas
Decision Date1997-04-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3 DIMENSIONAL VIDEO ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Oktas. It received FDA 510(k) clearance on 1997-04-14 under 510(k) number K970214. 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 3 DIMENSIONAL VIDEO ENDOSCOPE?

3 DIMENSIONAL VIDEO ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1997-04-14. The listed applicant is Oktas. The 510(k) number is K970214.

When did 3 DIMENSIONAL VIDEO ENDOSCOPE receive FDA 510(k) clearance?

3 DIMENSIONAL VIDEO ENDOSCOPE received FDA 510(k) clearance on 1997-04-14, under 510(k) number K970214.

Who is the listed applicant for 3 DIMENSIONAL VIDEO ENDOSCOPE?

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 3 DIMENSIONAL VIDEO ENDOSCOPE?

The FDA product code for 3 DIMENSIONAL VIDEO ENDOSCOPE 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.

K970369VISTA MINI CAMERA SYSTEMK9611823D SCOPEK946171VIDEO 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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