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FDA 510(k)

Acessa ProVu System

K-Number: K181124 · 2018-09-28

ApplicantAcessa Health, Inc.
Decision Date2018-09-28
Product CodeHFG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Acessa ProVu System is a medical device manufactured by Acessa Health, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K181124. The device is classified under product code HFG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acessa ProVu System?

Acessa ProVu System is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Acessa Health, Inc.. The 510(k) number is K181124.

When was Acessa ProVu System approved by the FDA?

Acessa ProVu System received FDA 510(k) clearance on 2018-09-28, under approval number K181124.

What company makes Acessa ProVu System?

Acessa ProVu System is manufactured by Acessa Health, Inc..

What is the FDA product code for Acessa ProVu System?

The FDA product code for Acessa ProVu System is HFG.

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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