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FDA 510(k)

Combi Touch

K-Number: K231391 · 2023-05-15

Decision Date2023-05-15
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Combi Touch is the device name listed in this FDA 510(k) record. The listed applicant is Mectron S.P.A.. It received FDA 510(k) clearance on 2023-05-15 under 510(k) number K231391. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Combi Touch?

Combi Touch is a medical device that received FDA 510(k) clearance on 2023-05-15. The listed applicant is Mectron S.P.A.. The 510(k) number is K231391.

When did Combi Touch receive FDA 510(k) clearance?

Combi Touch received FDA 510(k) clearance on 2023-05-15, under 510(k) number K231391.

Who is the listed applicant for Combi Touch?

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

What is the FDA product code for Combi Touch?

The FDA product code for Combi Touch is ELC.

Other records listing Mectron S.P.A. 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.

Related Devices (Code: ELC)

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.

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.