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FDA 510(k)

CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)

K-Number: K950747 · 1995-03-06

ApplicantStephen Chakoff, Inc.
Decision Date1995-03-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) is the device name listed in this FDA 510(k) record. The listed applicant is Stephen Chakoff, Inc.. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K950747. 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 CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)?

CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Stephen Chakoff, Inc.. The 510(k) number is K950747.

When did CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) receive FDA 510(k) clearance?

CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) received FDA 510(k) clearance on 1995-03-06, under 510(k) number K950747.

Who is the listed applicant for CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)?

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

What is the FDA product code for CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)?

The FDA product code for CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.) is GCJ.

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Other records listing Stephen Chakoff, Inc. 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.

K940316HYSTERSCOPEK940317SINUSCOPEK950753CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIOK951082CHAKOFF ENDOSCOPY, RIGID ENDOSCOPEK950744CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)K950748CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE)

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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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