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FDA 510(k)

OKTAS STEREO VIEWING SYSTEM

K-Number: K944254 · 1994-11-30

ApplicantOktas
Decision Date1994-11-30
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OKTAS STEREO VIEWING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oktas. It received FDA 510(k) clearance on 1994-11-30 under 510(k) number K944254. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OKTAS STEREO VIEWING SYSTEM?

OKTAS STEREO VIEWING SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Oktas. The 510(k) number is K944254.

When did OKTAS STEREO VIEWING SYSTEM receive FDA 510(k) clearance?

OKTAS STEREO VIEWING SYSTEM received FDA 510(k) clearance on 1994-11-30, under 510(k) number K944254.

Who is the listed applicant for OKTAS STEREO VIEWING SYSTEM?

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 OKTAS STEREO VIEWING SYSTEM?

The FDA product code for OKTAS STEREO VIEWING SYSTEM is FET.

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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 SYSTEMK9611823D SCOPEK946171VIDEO ENDOSCOPE SYSTEM WITH ZOOMK944256OKTAS INTRA-ORAL DENTAL CAMERAK941919OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM

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Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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