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FDA 510(k)

MECTA Sigma

K-Number: K192834 · 2020-04-26

ApplicantMecta Corporation
Decision Date2020-04-26
Product CodeQGH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MECTA Sigma is the device name listed in this FDA 510(k) record. The listed applicant is Mecta Corporation. It received FDA 510(k) clearance on 2020-04-26 under 510(k) number K192834. The device is classified under product code QGH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECTA Sigma?

MECTA Sigma is a medical device that received FDA 510(k) clearance on 2020-04-26. The listed applicant is Mecta Corporation. The 510(k) number is K192834.

When did MECTA Sigma receive FDA 510(k) clearance?

MECTA Sigma received FDA 510(k) clearance on 2020-04-26, under 510(k) number K192834.

Who is the listed applicant for MECTA Sigma?

The FDA 510(k) record lists Mecta Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MECTA Sigma?

The FDA product code for MECTA Sigma is QGH.

Other records listing Mecta Corporation 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

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

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