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FDA 510(k)

MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L

K-Number: K993568 · 2000-03-13

ApplicantMachida Endoscope Co., Ltd.
Decision Date2000-03-13
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L is the device name listed in this FDA 510(k) record. The listed applicant is Machida Endoscope Co., Ltd.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K993568. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L?

MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Machida Endoscope Co., Ltd.. The 510(k) number is K993568.

When did MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L receive FDA 510(k) clearance?

MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L received FDA 510(k) clearance on 2000-03-13, under 510(k) number K993568.

Who is the listed applicant for MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L?

The FDA 510(k) record lists Machida Endoscope Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L?

The FDA product code for MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L is GWG.

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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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