FDA 510(k)

TRIO 300

K-Number: K990787 · 1999-10-20

Decision Date1999-10-20

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

TRIO 300 is the device name listed in this FDA 510(k) record. The listed applicant is Ito Co., Ltd.. It received FDA 510(k) clearance on 1999-10-20 under 510(k) number K990787. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIO 300?

TRIO 300 is a medical device that received FDA 510(k) clearance on 1999-10-20. The listed applicant is Ito Co., Ltd.. The 510(k) number is K990787.

When did TRIO 300 receive FDA 510(k) clearance?

TRIO 300 received FDA 510(k) clearance on 1999-10-20, under 510(k) number K990787.

Who is the listed applicant for TRIO 300?

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

What is the FDA product code for TRIO 300?

The FDA product code for TRIO 300 is IPF.

Other records listing Ito Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.