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FDA 510(k)

3-CCD DIGITAL CAMERA

K-Number: K970605 · 1997-05-22

ApplicantEnvision Medical Corp.
Decision Date1997-05-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3-CCD DIGITAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Envision Medical Corp.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K970605. 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-CCD DIGITAL CAMERA?

3-CCD DIGITAL CAMERA is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Envision Medical Corp.. The 510(k) number is K970605.

When did 3-CCD DIGITAL CAMERA receive FDA 510(k) clearance?

3-CCD DIGITAL CAMERA received FDA 510(k) clearance on 1997-05-22, under 510(k) number K970605.

Who is the listed applicant for 3-CCD DIGITAL CAMERA?

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

What is the FDA product code for 3-CCD DIGITAL CAMERA?

The FDA product code for 3-CCD DIGITAL CAMERA is GCJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Envision Medical Corp. 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.

K953438SURGICAL INTEGRATED CAMERA SYSTEMK951971XENON LIGHT SOURCEK944707ISOLATED CAMERA HEADK934092CAMERA, SURGICAL AND ACCESSORIES

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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