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FDA 510(k)

SERI Contour

K-Number: K172545 · 2017-09-22

ApplicantSofregen Medical, Inc.
Decision Date2017-09-22
Product CodeOXF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERI Contour is a medical device manufactured by Sofregen Medical, Inc.. It received FDA 510(k) clearance on 2017-09-22 under approval number K172545. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERI Contour?

SERI Contour is a medical device that received FDA 510(k) clearance on 2017-09-22. It is manufactured by Sofregen Medical, Inc.. The 510(k) number is K172545.

When was SERI Contour approved by the FDA?

SERI Contour received FDA 510(k) clearance on 2017-09-22, under approval number K172545.

What company makes SERI Contour?

SERI Contour is manufactured by Sofregen Medical, Inc..

What is the FDA product code for SERI Contour?

The FDA product code for SERI Contour is OXF.

Other Devices by Sofregen Medical, Inc.

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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.

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