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FDA 510(k)

HITACHI VERSIFLEX

K-Number: K991231 · 1999-05-24

ApplicantHitachi Medical Systems America, Inc.
Decision Date1999-05-24
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HITACHI VERSIFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 1999-05-24 under 510(k) number K991231. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HITACHI VERSIFLEX?

HITACHI VERSIFLEX is a medical device that received FDA 510(k) clearance on 1999-05-24. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K991231.

When did HITACHI VERSIFLEX receive FDA 510(k) clearance?

HITACHI VERSIFLEX received FDA 510(k) clearance on 1999-05-24, under 510(k) number K991231.

Who is the listed applicant for HITACHI VERSIFLEX?

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

What is the FDA product code for HITACHI VERSIFLEX?

The FDA product code for HITACHI VERSIFLEX is IZI.

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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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