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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Enterprises, Inc.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) 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. The listed applicant is Biomedical Enterprises, Inc.. The 510(k) number is K153573.

When did Converge receive FDA 510(k) clearance?

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

Who is the listed applicant for Converge?

The FDA 510(k) record lists Biomedical Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Converge?

The FDA product code for Converge is HRS.

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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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