FS Ergo
K-Number: K173646 · 2017-12-19
ApplicantPalodex Group OY
Decision Date2017-12-19
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
FS Ergo is a medical device manufactured by Palodex Group OY. It received FDA 510(k) clearance on 2017-12-19 under approval number K173646. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FS Ergo?
FS Ergo is a medical device that received FDA 510(k) clearance on 2017-12-19. It is manufactured by Palodex Group OY. The 510(k) number is K173646.
When was FS Ergo approved by the FDA?
FS Ergo received FDA 510(k) clearance on 2017-12-19, under approval number K173646.
What company makes FS Ergo?
FS Ergo is manufactured by Palodex Group OY.
What is the FDA product code for FS Ergo?
The FDA product code for FS Ergo is MUH.
Other Devices by Palodex Group OY
Related Devices (Code: MUH)
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.