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FDA 510(k)

TM-400

K-Number: K081247 · 2008-08-25

ApplicantIto Co., Ltd.
Decision Date2008-08-25
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TM-400 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 2008-08-25 under 510(k) number K081247. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TM-400?

TM-400 is a medical device that received FDA 510(k) clearance on 2008-08-25. The listed applicant is Ito Co., Ltd.. The 510(k) number is K081247.

When did TM-400 receive FDA 510(k) clearance?

TM-400 received FDA 510(k) clearance on 2008-08-25, under 510(k) number K081247.

Who is the listed applicant for TM-400?

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 TM-400?

The FDA product code for TM-400 is ITH.

Other records listing Ito Co., Ltd. as applicant

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Related Devices (Code: ITH)

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.

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