FDA 510(k)

MTC XI UL

K-Number: K871178 · 1987-10-09

Decision Date1987-10-09

Product CodeFMT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MTC XI UL is the device name listed in this FDA 510(k) record. The listed applicant is Aragona Medical, Inc.. It received FDA 510(k) clearance on 1987-10-09 under 510(k) number K871178. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTC XI UL?

MTC XI UL is a medical device that received FDA 510(k) clearance on 1987-10-09. The listed applicant is Aragona Medical, Inc.. The 510(k) number is K871178.

When did MTC XI UL receive FDA 510(k) clearance?

MTC XI UL received FDA 510(k) clearance on 1987-10-09, under 510(k) number K871178.

Who is the listed applicant for MTC XI UL?

The FDA 510(k) record lists Aragona Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTC XI UL?

The FDA product code for MTC XI UL is FMT.

Other records listing Aragona Medical, Inc. 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.

K871177NTH 101 UL

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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.