MED RF 4000
K-Number: K210077 · 2021-12-17
ApplicantF Care Systems USA, LLC
Decision Date2021-12-17
Product CodeONQ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MED RF 4000 is a medical device manufactured by F Care Systems USA, LLC. It received FDA 510(k) clearance on 2021-12-17 under approval number K210077. The device is classified under product code ONQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MED RF 4000?
MED RF 4000 is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by F Care Systems USA, LLC. The 510(k) number is K210077.
When was MED RF 4000 approved by the FDA?
MED RF 4000 received FDA 510(k) clearance on 2021-12-17, under approval number K210077.
What company makes MED RF 4000?
MED RF 4000 is manufactured by F Care Systems USA, LLC.
What is the FDA product code for MED RF 4000?
The FDA product code for MED RF 4000 is ONQ.
Other Devices by F Care Systems USA, LLC
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.