AposTherapy System
K-Number: K182090 · 2018-11-16
ApplicantApos Medical Assets , Ltd.
Decision Date2018-11-16
Product CodeQDT
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
AposTherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Apos Medical Assets , Ltd.. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K182090. The device is classified under product code QDT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AposTherapy System?
AposTherapy System is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Apos Medical Assets , Ltd.. The 510(k) number is K182090.
When did AposTherapy System receive FDA 510(k) clearance?
AposTherapy System received FDA 510(k) clearance on 2018-11-16, under 510(k) number K182090.
Who is the listed applicant for AposTherapy System?
The FDA 510(k) record lists Apos Medical Assets , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AposTherapy System?
The FDA product code for AposTherapy System is QDT.
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.