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FDA 510(k)

Converge

K-Number: K153573 · 2016-08-11

ApplicantBiomedical Enterprises, Inc.
Decision Date2016-08-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Converge is a medical device manufactured by Biomedical Enterprises, Inc.. It received FDA 510(k) clearance on 2016-08-11 under approval number K153573. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Converge?

Converge is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Biomedical Enterprises, Inc.. The 510(k) number is K153573.

When was Converge approved by the FDA?

Converge received FDA 510(k) clearance on 2016-08-11, under approval number K153573.

What company makes Converge?

Converge is manufactured by Biomedical Enterprises, Inc..

What is the FDA product code for Converge?

The FDA product code for Converge is HRS.

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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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