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FDA 510(k)

AIRIS, AIRIS II

K-Number: K992650 · 1999-10-08

ApplicantHitachi Medical Systems America, Inc.
Decision Date1999-10-08
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIRIS, AIRIS II 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 1999-10-08 under 510(k) number K992650. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRIS, AIRIS II?

AIRIS, AIRIS II is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K992650.

When did AIRIS, AIRIS II receive FDA 510(k) clearance?

AIRIS, AIRIS II received FDA 510(k) clearance on 1999-10-08, under 510(k) number K992650.

Who is the listed applicant for AIRIS, AIRIS II?

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 AIRIS, AIRIS II?

The FDA product code for AIRIS, AIRIS II is MOS.

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Related Devices (Code: MOS)

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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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