hipEOS
K-Number: K161479 · 2016-06-28
ApplicantOnefit Medical
Decision Date2016-06-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
hipEOS is a medical device manufactured by Onefit Medical. It received FDA 510(k) clearance on 2016-06-28 under approval number K161479. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the hipEOS?
hipEOS is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by Onefit Medical. The 510(k) number is K161479.
When was hipEOS approved by the FDA?
hipEOS received FDA 510(k) clearance on 2016-06-28, under approval number K161479.
What company makes hipEOS?
hipEOS is manufactured by Onefit Medical.
What is the FDA product code for hipEOS?
The FDA product code for hipEOS is LLZ.
Other Devices by Onefit Medical
Related Devices (Code: LLZ)
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.