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 a medical device manufactured by Mecta Corporation. It received FDA 510(k) clearance on 2020-04-26 under approval 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. It is manufactured by Mecta Corporation. The 510(k) number is K192834.
When was MECTA Sigma approved by the FDA?
MECTA Sigma received FDA 510(k) clearance on 2020-04-26, under approval number K192834.
What company makes MECTA Sigma?
MECTA Sigma is manufactured by Mecta Corporation.
What is the FDA product code for MECTA Sigma?
The FDA product code for MECTA Sigma is QGH.
Other Devices by Mecta Corporation
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.