FDA 510(k)

TCM400

K-Number: K001866 · 2000-12-07

Decision Date2000-12-07

Product CodeLPP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TCM400 is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical A/S. It received FDA 510(k) clearance on 2000-12-07 under 510(k) number K001866. The device is classified under product code LPP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCM400?

TCM400 is a medical device that received FDA 510(k) clearance on 2000-12-07. The listed applicant is Radiometer Medical A/S. The 510(k) number is K001866.

When did TCM400 receive FDA 510(k) clearance?

TCM400 received FDA 510(k) clearance on 2000-12-07, under 510(k) number K001866.

Who is the listed applicant for TCM400?

The FDA 510(k) record lists Radiometer Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TCM400?

The FDA product code for TCM400 is LPP.

Other records listing Radiometer Medical A/S 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.

K002290ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

Related Devices (Code: LPP)

K885079HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275Mennen Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.