FDA 510(k)

OPERA, OPERA eco

K-Number: K190810 · 2019-08-30

Decision Date2019-08-30

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

OPERA, OPERA eco is a medical device manufactured by Unimom.Co. It received FDA 510(k) clearance on 2019-08-30 under approval number K190810. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERA, OPERA eco?

OPERA, OPERA eco is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Unimom.Co. The 510(k) number is K190810.

When was OPERA, OPERA eco approved by the FDA?

OPERA, OPERA eco received FDA 510(k) clearance on 2019-08-30, under approval number K190810.

What company makes OPERA, OPERA eco?

OPERA, OPERA eco is manufactured by Unimom.Co.

What is the FDA product code for OPERA, OPERA eco?

The FDA product code for OPERA, OPERA eco is HGX.

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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.