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FDA 510(k)

VISIJET HYDROKERATOME, MODEL 50

K-Number: K991124 · 2000-10-20

ApplicantVisijet, Inc.
Decision Date2000-10-20
Product CodeMYD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISIJET HYDROKERATOME, MODEL 50 is the device name listed in this FDA 510(k) record. The listed applicant is Visijet, Inc.. It received FDA 510(k) clearance on 2000-10-20 under 510(k) number K991124. The device is classified under product code MYD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIJET HYDROKERATOME, MODEL 50?

VISIJET HYDROKERATOME, MODEL 50 is a medical device that received FDA 510(k) clearance on 2000-10-20. The listed applicant is Visijet, Inc.. The 510(k) number is K991124.

When did VISIJET HYDROKERATOME, MODEL 50 receive FDA 510(k) clearance?

VISIJET HYDROKERATOME, MODEL 50 received FDA 510(k) clearance on 2000-10-20, under 510(k) number K991124.

Who is the listed applicant for VISIJET HYDROKERATOME, MODEL 50?

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

What is the FDA product code for VISIJET HYDROKERATOME, MODEL 50?

The FDA product code for VISIJET HYDROKERATOME, MODEL 50 is MYD.

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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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