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FDA 510(k)

ALTAIRE

K-Number: K050602 · 2005-04-07

ApplicantHitachi Medical Systems America, Inc.
Decision Date2005-04-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALTAIRE 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 2005-04-07 under 510(k) number K050602. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTAIRE?

ALTAIRE is a medical device that received FDA 510(k) clearance on 2005-04-07. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K050602.

When did ALTAIRE receive FDA 510(k) clearance?

ALTAIRE received FDA 510(k) clearance on 2005-04-07, under 510(k) number K050602.

Who is the listed applicant for ALTAIRE?

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 ALTAIRE?

The FDA product code for ALTAIRE is LNH.

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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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