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 the device name listed in this FDA 510(k) record. The listed applicant is Acessa Health, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) 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. The listed applicant is Acessa Health, Inc.. The 510(k) number is K181124.
When did Acessa ProVu System receive FDA 510(k) clearance?
Acessa ProVu System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181124.
Who is the listed applicant for Acessa ProVu System?
The FDA 510(k) record lists Acessa Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Acessa ProVu System?
The FDA product code for Acessa ProVu System is HFG.
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.